sromelRicux June 14, 2013 Urgent Product Correction Notice Dear Valued bioMérieux Customer, ur records indicate you have received one or more of the following VITEK* 2 Software version 6.01 products: Part Number Product Description ‘413861 __| KIT, V2S 6.01 RPS8O0-WES7 MEDIA “414537___| KIT UPDT V25 6.01 MLL 414538 __| KIT UPDT V25 6.01 ML2 “414539 | KIT UPDTV25 6.01 DE “414560___| KIT UPDTV25 6.01 EN ‘414561__| KIT UPDTV25 6.01 ES ‘414562___| KIT UPDTV25 6.01 FR 414563 | KIT UPDTV25 6.01 IT 414564 | KITUPDTV25 6.01 1A “414565 | KIT UPDTV2S 6.01 NO “414566 | KIT UPDTV2S 6.01 PT 414567 | KIT UPDTV2S 6.01 DA, SV 414568 | KITUPDTV2S6.01 EL, TR 414569___| KIT UPDTV2S 6.01 2H “415700__| VITEK 2 KIT MISE A JOUR 601 FR 16201773 | KIT V2S RPS8OOXPE to 6.01 WES7 (6201842 | DVD, VITEK 2 0C7100 IMAGE 6.01 16201843 | DVD, VITEK 2 DC7700 IMAGE 6.01 16201844 | DVD, VITEK 2 DC7800 IMAGE 6.01 (6201845 | DVD, VITEK 2 RPS800 IMAGE 6.01 This letter is intended for customers performing update of software from version 5.xx to 6.01 Software with their VITEK® 2 system. A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). New VITEK 2 Systems and new PC 6.01 installs are not impacted by this issue. However, we recommend that you confirm the issue described below is not encountered. Description of the Issue: During the update of software from version 5.xx to 6.01, the Bi-directional Computer Interface (BC!) antibiotic codes are not updated properly for Cefovecin (CFO), Prulfloxacin (PRU) and Ceftaroline (CTL). For the referenced antibiotics, the bioMérieux code in the reference table does not match the default hast code in version 6.01 software, Antibiotic name bioMérieuxcode Default host code Cefovecin (veterinary only antibiotic) CFO) atl Prulifloxacin (deduced antibiotic) PRU fo Ceftaroline (not released for use, but could be deduced) cr pru The discrepancy in the BC! antibiotic translation table Impacts the results that are uploaded to the LIS through the BC interface. 100 Rodolphe Street # Durham, NC 27712 « Tel: 919 620-2000 ‘www biomerieux.com FA 1782 PIN 9305553promélrieux ‘© Cefovecin results on the VITEK® 2 would be uploaded to the LIS through BCI interface as Ceftaroline. ‘© Prulificxacin results on the VITEK* 2 would be uploaded to the LiS through BCI interface as Cefovecin. + Ceftaroline results on the VITEK® 2 would be uploaded to the LIS through BCI interface as Prulifloxacin ‘The identified anomaly only affects customers with software version 6.01 that are interfaced with a US and are not interfaced with OBSERVA®. New VITEK 2 Systems or new PC6.01 installs are not impacted by this anomaly; the discrepancy isin the update process for 5.2x to 6.01 and not in the install process. Impact to customer: The impact and subsequent consequence of the antibiotic code discrepancy for Cefovecin, Prulifloxacin and Ceftaroline is that the incorrect AST test result could be sent to the LIS. If the incorrect code for the referenced antibiotics is sent, then there is a potential for misinterpretation of antibiotic codes. ‘The following summarizes the impact of each discrepancy: + Cefovecin -> Ceftaroline : The results in VITEK® 2 remain correct for Cefovecin. Ther results. This discrepancy only impacts veterinary patients. © Prulifloxacin > Cefovecin : Prulfloxacin is an antibiotic that can only be deduced. If the antibiotic is chosen for deduction, the results in VITEK® 2 would remain correct and the incorrect antibiotic name would be sent to the US. Itis likely that the result would be questioned since it is a veterinary antibiotic. The impact is considered negligible because Cefovecin sent to the LIS is an antibiotic that is not used to treat humans. * Ceftaroline > Prulifloxacin: Ceftaroline is not currently available for testing on VITEK* 2 cards, but is available for deduction. The deduced result for Ceftaroline would be sent to the LIS as Prulifoxacin. In this case, there is 2 risk of mis-interpretation of antibiotic codes, which could lead to reporting incorrect, antibiotic results from the LIS. ‘no impact to clinical Required Actions: We request you take the following actions at this time: 1L. Ensure this Urgent Product Correction Notice and the Instructions for modifying BC! Translation Codes (Attachment) are distributed to all appropriate personnel in your organization. 2. Follow the instructions in the attached file (Instructions for modifying BC! Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table 3. Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice. bioMérieux will incorporate a software solution to prevent this issue from occurring, in the next software update, version 7.01 targeted for launch at the end of 2013. bloMérieux is committed to providing our customers with the highest quality product. We apologize for any inconvenience this may have caused you. if you require additional assistance or have any questions, please contact your local bioMérieux Clinical Customer Service organization at (800) 682-2666 or Industral Customer Service organization at (800) 634-7656. ‘Thank you for your continued use of bioMérieux products, Sincerely, OU Bah ‘Alan Bergold, PhD Director QA/RA North American Commercial Operations 100 Rodolphe Street * Durham, NC 27712 « Tel: 919 620-2000 ‘www. biomerieux.com FA 1782 P/N 9305553siomeRicux Attachment A: Acknowledgement Form. URGENT PRODUCT CORRECTION NOTICE FSCA - 1782 - VITEK® 2 (6.01 Software) Mis-interpretation of antibiotic codes sent to LIS Customer Information: Customer Account Number: Organization Name: Street Address: City, State and Postal Code: Contact Name: Contact Title: Phone Number: Product Information: 413861 KIT, V2S 6.01 RPS800-WES7 MEDIA 414566 | KIT UPDTV2S6.01 PT “414537 KIT UPDT V25 6.01 MLL ‘414567 __| KIT UPDTV2S6.01 DA, SV = 414538 KIT UPDT V25 6.01 MLZ 414568 | KITUPDTV2S 6.01 EL, TR 414539. KIT UPDT V25 6.01 DE -414569__| KITUPDT V2 6.01 2H “414560 KIT UPDT V25 6.01. EN 415700___| VITEK 2 KIT MISE A JOUR 6.01 FR 414561 KITUPDT V2S 6.01 ES ‘6201773 | KIT V2S RPSBOOXPE to 6.01 WES7 14562 KIT UPDT V25 6.01 FR 16201842 | DVD, VITEK 2 DC7100 IMAGE 6.01 14563, KIT UPDT V25 6.01 T 16201843 | DVD, VITEK 2 0C7700 IMAGE 6.01 414564 KIT UPDT V25 6.01.18 16201844 | DVD, VITEK 2 0C7800 IMAGE 6.01 14565 KIT UPDT V25 6.01 NO 6201845 | DVD, VITEK 2 RP58O0 IMAGE 6.01 ‘Questions: Yes | No 4. Did you read the enclosed Urgent Product Correction Notice regarding VITEK”2 systems? 2, Have you followed the instructions and implemented the actions as indicated in this Urgent Product Correction Notice? 3, Have you received reports of injury to patient, unnecessary medical procedure or delay in a necessary medical procedure related to the VITEK 2 BCI antibiotic code discrepancy? ‘Comments: Signature: Date Its important that you complete this Acknowledgement Form and retum it to bioMérieux. Please fax this form to: (919) 287-2542) To the attention of: RA North American ComOps 100 Rodolphe Street ¢ Dutham, NC 27712 « Tel: 919 620-2000 ‘www.biomerieux.com FA 1782 PIN 9305553joMérieux, Inc. Instructions for modifying BCI Translation Codes 1. _Logonto the VITEK 2 software using an account of Supervisor level access (or higher). 2. Click Configuration and select BC! Configuration from the drop-down list 3. Atthe BCI Configuration screen, click on the lock icon to access configuration changes Page 1 of 4 193055514. Once configuration changes are accessed, highlight the connection to the LIS under “BCI Link Connections”. Click on the “Translation” tab and select “Antibiotic” from the drop down list Page 2 of 4 93055515. Inthe antibiotic table, locate and highlight Cefovecin. The Host Code of “ct!” is not the correct default code and will need to be changed Page 3 of 4 93055516. Tomodify the Host Code, double click in the “ctl” cell; a cursor will display indicating that the cell is active. Remove the Host Code of “ct!” by using the Backspace key on the keyboard and type the corrected Host Code in the cell. The default Host Code for Cefovecin is “cfo” 7. Click on the Save icon to save the modifications. 8 Repeat the modification instructions for Prulifloxacin (correct default Host Code to “pru”) and Ceftaroline (correct default Host Code to “ctl” 9. Once all configuration changes are saved, click on the lock icon to exit BCI Configuration. Page 4 of 4 9305551BIOME|RIEUX Impact of Results ‘Staphylococci can exhibit a high incidence of macrolide resistance and many alternative therapeutic choices are available. Therefore, it is unlikely that a physician would choose erythromycin to treat a patient with a staphylococcal infection, even if it were reported as susceptible. The concer in the case of a false susceptible result reported for erythromycin is the possibility that additional testing for inducible clindamycin resistance may not be performed. In many clinical microbiology laboratories, an additional test (D-zone disc diffusion test) is performed to look for evidence of inducible clindamycin resistance in Staphylococcus isolates that test as erythromycin resistant and Glindamycin susceptible by MIC or disc diffusion methods. The clinical significance of inducible clindamycin resistance is unclear because the drug may still be effective for some patients with mild infections; however, the presence of inducible resistance should preclude the use of clindamycin for more serious infections. Many VITEK® 2 AST-GP cards include an Inducible Clindamycin Resistance (ICR) test. The VITEK® 2 ICR test result mitigates the impact of a false susceptible erythromycin result. Considering that there are more effective therapies for staphylococcal infections than erythromycin and the availability of the ICR test on approximately 80% VITEK® 2 AST-GP cards used for staphylococci, the risk to patients due to the potential increase in very major errors when EUCAST andlor CA-SFM breakpoints are used for Erythromycine is considered to be remote. Short-term Actions 1. bioMérieux is requesting that laboratories using EUCAST or CA-SFM breakpoints for category interpretations of MICs implement Conditional Antibiotic Reporting for the VITEK® 2 (AIX) or a bIoART rule for VITEK® 2 PC Systems to suppress Erythromycine results from reporting for ‘Staphylococcus species isolates. 2. If possible, please use an AST-GP card that includes the ICR test. Contact your local bioMérieux representative if you need assistance to select an alternate card type. 3. If the VITEK® 2 AST-GP cards used in your laboratory do not contain the ICR test, bioMérieux recommends that you perform the manual D-zone disc diffusion test on Staphylococcus isolates, for the detection of inducible clindamycin resistance. Long-term Action ‘There is a new formulation of Erythromycin available on some VITEK® 2 AST cards that is not affected by the same category performance issue with Staphylococcus species when using EUCAST or CA-SFM breakpoints. Itis designated as Ee in the Code column of the VITEK® 2 AST Package Insert. Please contact your local bioMérieux representative to determine availabilty of cards with Erythromycine. If you have any questions or concerns, please contact your local bioMérieux representative. Thank you for your patience in this matter and for allowing bioMérieux to continue to serve your laboratory needs. Sincerely, bioMérieux, Inc. 414465 Page 2 of 2BIOME|RIEUX PRODUCT CORRECTION NOTICE - FOLLOW-UP COMMUNICATION VITEK® 2 AST-GP Erythromycin® EUCAST Limitation Dear bioMérieux VITEK® 2 Customer, 10-SEP-2012 New Limitation for VITEK® 2 Gram Positive AST Erythromycin@: Staphylococcus spp. When Applying EUCAST® Interpretation Standards This letter is intended for all customers using VITEK® 2 Gram Positive (GP) Antimicrobial Susceptibility Test (AST) cards containing Erythromycine* and applying European Committee on Antimicrobial ‘Susceptibility Testing (EUCAST) or Comité de I'Antibiogramme de la Societé Francaise de Microbiologie (CA-SFM) Interpretation Standards (breakpoints) in the VITEK® 2 Software. * Refer to the VITEK® 2 AST Package Insert to determine if the cards used in your laboratory contain the Erythromycine formulation, designated as Ee in the Code column, Description of the Issue In May 2011, bioMérieux sent a communication (ref 9300784) to inform customers about a shift in the AST-GP Erythromycine MIC interpretation category agreement compared to susceptibility reference testing for Staphylococcus when EUCAST or CA-SFM breakpoints (< 1: S, >2: R) are applied. Despite rigorous efforts to resolve the issue with Erythromycine since that communication was distributed, we have been unable to make changes that would allow this version of Erythromycin to meet ‘originally published category performance when using EUCAST (or CA-SFM) breakpoints for Staphylococcus isolates. Based on these findings, bioMérieux recommends Erythromycine results be suppressed from reporting (or suppressed from analysis) for Staphylococcus isolates with EUCAST or CA-SFM interpretations applied and that an alternate method be performed prior to reporting results for this antimicrobialiorganism combination. This recommendation is effective immediately. Erythromycine results can be suppressed using a Conditional Antibiotic Reporting rule for the VITEK® 2 (AIX) or by the use of a bioART rule for VITEK® 2 PC Systems. A limitation will be added to the VITEK® 2 AST Limitations with EUCAST Breakpoints Table in the VITEK® 2 Systems Product Information manual in a future VITEK® 2 Systems (PC) software version. Note: There are no further software updates for VITEK® 2 AIX computers. Perform an alternate method of testing prior to reporting results for Erythromycine: Staphylococcus spp. Essential and Category Agreement for Staphylococci and Erythromycin meet the FDA-defined category acceptance criteria when Clinical and Laboratory Standards Institute (CLSI®) interpretation standards (£05S, 1-41, > 8 R) are applied, 414465 Page 1 of 2