BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 AST-N351

    MDR report key: 8148200 · Received December 10, 2018

    Report

    Report Number
    1950204-2018-00636
    Event Type
    Injury
    Date Received
    December 10, 2018
    Report Date
    April 1, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED IN RESPONSE TO CUSTOMER COMPLAINTS REPORTING AN INCREASE IN THE FREQUENCY OF ESBL PHENOTYPE DETECTION BY THE ADVANCED EXPERT SYSTEM (AES) FOLLOWING THE UPDATE TO VITEK 2 SYSTEMS (V2S) SOFTWARE VERSION 8.01. TESTING BY ALTERNATE METHODS HAS NOT CONFIRMED THE PRESENCE OF ESBL IN IMPACTED STRAINS. CONCLUSION: IN THE AES VERSION 8.01 OF THE VITEK2 SOFTWARE, THE MIC RANGES FOR E. COLI AND PIPERACILLIN/TAZOBACTAM WERE CHANGED FOR THE 'ACQUIRED PENICILLINASE' AND 'INHIBITOR RESISTANT PENICILLINASE' PHENOTYPES. THESE CHANGES CONSISTED IN REMOVING MICS >=128 MG/L AS POSSIBLE MICS FOR BOTH PHENOTYPES. THE CONSEQUENCE IS THAT THIS CHANGE HAS REVEALED A PREEXISTING ISSUE IN THE AES DEFINITION OF THE CEFUROXIME MIC RANGE FOR E. COLI AND ESBLS (CEFUROXIME MICS <=8 MG/L SHOULD PREVENT THE ESBL PROPOSAL). THIS, IN ADDITION TO THE SPECIFIC ANTIBIOTIC CONFIGURATION OF THE AST-N351 CARD AND ABSENCE OF THE ESBL TEST, IS THE ROOT CAUSE OF THE REPORTED INCREASE IN ESBL PHENOTYPE PROPOSAL FOR THE AST-N351 CARD. THIS ISSUE WILL BE CORRECTED IN VITEK 2 SYSTEMS SOFTWARE VERSION 9.02. IT SHOULD BE NOTED THAT THERE ARE NO PUBLISHED PERFORMANCE CLAIMS FOR PHENOTYPE DETECTION BY AES. A FIELD SAFETY CORRECTIVE ACTION (FSCA 4191-1) WAS ISSUED 13-DEC-2018 TO THE (B)(6) TO ADDRESSES THIS ISSUE IN THE FIELD. THE ASSOCIATED URGENT PRODUCT CORRECTION NOTICE INFORMS CUSTOMERS OF THE ESBL PHENOTYPE PROPOSAL AND DESCRIBES CRITERIA LIMITATIONS TO BE APPLIED VIA A VITEK® 2 BIOART RULE. PMA/510(K) NUMBER CORRECTED TO N50510: S103.

    Description of Event or Problem · 1

    ON 12-NOV-2018, BIOMÉRIEUX RECEIVED INFORMATION FROM A CUSTOMER IN THE (B)(6) REGARDING FALSE POSITIVE DETECTION OF ESBL PHENOTYPE WHEN TESTING ESCHERICHIA COLI WITH THE VITEK® 2 AST-N351 TEST KIT (REF 421257). THE CUSTOMER'S SYSTEM WAS OPERATING WITH VITEK 2 SYSTEMS SOFTWARE VERSION 8.01. THE CUSTOMER REPORTED THAT A NEONATAL PATIENT WAS COHABITATED WITH ANOTHER ESBL POSITIVE PATIENT BASED ON AN INCORRECT RESULT THAT PROPOSED THE ESBL PHENOTYPE FOR THE ESCHERICHIA COLI ISOLATE OBTAINED FROM THIS PATIENT. FOLLOWING A CORRECTED REPORT, THE PATIENT UNDERWENT ADDITIONAL SCREENING TO ENSURE THERE HAD BEEN NO CROSS-INFECTION FROM COHABITATING WITH THE OTHER ESBL POSITIVE PATIENT. NO FURTHER DETAILS ABOUT THE PATIENT'S SYMPTOMS, CO-MORBIDITIES, PRE-TEST ANTIBIOTIC THERAPY, OR OUTCOME WERE PROVIDED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987790 VITEK® 2 AST-N351 VITEK® 2 AST-N351 LON BIOMERIEUX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention