BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN09 TEST KIT

    MDR report key: 7849048 · Received September 5, 2018

    Report

    Report Number
    1950204-2018-00329
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Report Date
    November 13, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K161227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) SUBMITTED FIVE ESCHERICHIA COLI STRAINS FOR CEFEPIME (FEP) EVALUATION BECAUSE TWO LOTS OF AST-GN09 CARDS AND ONE LOT OF AST-N334 CARDS GAVE SUSCEPTIBLE RESULTS FOR THESE STRAINS. KIRBY-BAUER AND BROTH MICRODILUTION GAVE RESISTANT RESULTS. IDENTIFICATION OF THE ISOLATES WAS CONFIRMED, AND TESTING INCLUDED TWO CUSTOMER LOTS OF AST-GN09 CARDS (1060699203 AND 1060543103) AND ONE RANDOM LOT OF AST-GN09 CARDS. AGAR DILUTION (AD), THE REFERENCE METHOD FOR FEP02N, THE FEP FORMULATION FOUND ON THE AST-GN09 CARD, WAS PERFORMED. FOR ISOLATE 911685: ALL THREE AST-GN09 CARDS GAVE FEP MICS=2. AD ALSO GAVE AN MIC=2. CARDS AND REFERENCE METHOD ARE IN AGREEMENT FOR THESE CARDS. FOR ISOLATE 911686: ALL THREE AST-GN09 CARDS GAVE FEP MICS=2, AND AD GAVE AN MIC=4. CARDS AND REFERENCE METHOD ARE IN AGREEMENT. FOR ISOLATE 911687: ALL THREE AST-GN09 CARDS GAVE FEP MICS=2, AND AD GAVE AN MIC=4. CARDS AND REFERENCE METHOD ARE IN AGREEMENT. FOR ISOLATE 911688: ALL THREE AST-GN09 CARDS GAVE FEP MICS<=1, AND AD GAVE AN MIC=1. CARDS AND REFERENCE METHOD ARE IN AGREEMENT. FOR ISOLATE 911689: CUSTOMER LOT (1060699203) AND THE RANDOM LOT OF AST-GN09 CARDS GAVE MICS=2. AD GAVE AN MIC=4. FOR THESE TWO CARDS GIVING MICS=2, CARD AND REFERENCE METHOD RESULTS ARE ONLY ONE DOUBLING DILUTION APART, WHICH IS ACCEPTABLE FOR VITEK 2. IN SUMMARY: FOR THE VITEK 2 AST-GN09 CARDS, LOT 1060699203, THE CARDS AND REFERENCE METHOD (AD) ARE IN AGREEMENT FOR THE FIVE ISOLATES TESTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE SUSCEPTIBLE CEFEPIME RESULTS FOR ESCHERICHIA COLI STRAINS FROM FIVE (5) PATIENTS, IN ASSOCIATION WITH THE VITEK® 2 AST-GN09 TEST KIT (LOT 1060699203). THE CUSTOMER REPORTED THAT THE AST-GN09 CARD GAVE A CEFEPIME FALSE SUSCEPTIBLE RESULT TWICE, AND THE KIRBY-BAUER DISK TEST WAS RESISTANT. THE FIVE (5) PATIENT STRAINS WERE FROM DIFFERENT SOURCES (BLOOD, URINE, SPUTUM, URINE, CSF). THESE STRAINS WERE THEN SENT TO (B)(4) BIOMÉRIEUX AND FURTHER TESTING WAS PERFORMED. THE STRAINS WERE TESTED USING THE VITEK 2 AST-GN09 (FEP02N) AND AST-N334 (FEP03N) CARDS, ATB (BIOMÉRIEUX REAGENTS), AND BROTH MICRODILUTION (BMD). THE RESULTS FOR AST-GN09, AST-N334, AND ATB WERE SUSCEPTIBLE WHEN COMPARED TO BMD WHICH WAS RESISTANT. THE CUSTOMER STATED THERE WAS NO IMPACT TO THE PATIENTS. IT IS NOT KNOWN WHICH RESULTS WERE REPORTED TO A PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688562 VITEK® 2 AST-GN09 TEST KIT VITEK® 2 AST-GN09 TEST KIT LON BIOMERIEUX, INC. 1060699203

    Patients

    Seq Age Sex Outcome Treatment
    1