BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN95 TEST KIT

    MDR report key: 7893636 · Received September 20, 2018

    Report

    Report Number
    1950204-2018-00383
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026565923
    PMA / PMN Number
    K161217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR FALSE RESISTANT CEFTRIAXONE (CTR) RESULTS OBTAINED TWICE (MICS = 32 AND 8) WITH CAP 2018 D-12 SURVEY STRAIN, CITROBACTER BRAAKII, WHEN TESTING WITH THE VITEK® 2 AST-GN95 TEST KIT, LOT 6850485403. THE INTERNAL BIOMÉRIEUX CAP 2018 D-12 STRAIN WAS RE-HYDRATED, SUBCULTURED TO TSAB AND DEMONSTRATED TWO (2) DISTINCT COLONY MORPHOLOGIES. THE COLONIES WERE ISOLATED, AND THE IDENTIFICATIONS WERE CONFIRMED AS C. BRAAKII. TESTING INCLUDED VITEK AST-GN95 CARDS FROM THE CUSTOMER'S LOT (6850485403) IN DUPLICATE, AS WELL AS BROTH MICRODILUTION (BMD) AS THE REFERENCE METHOD FOR CRO02N FORMULATION FOUND IN THIS CARD, FOR BOTH STRAINS. ONLY TWO (2) LOTS OF VITEK 2 GN95 CARDS WERE MANUFACTURED TO DATE AND THE SECOND LOT (RANDOM LOT) WAS NOT AVAILABLE FOR THIS INVESTIGATION. TEST RESULTS ON STRAIN 911785 AND 911786 (BIOMÉRIEUX INTERNAL CAP STRAINS): ALL FOUR (4) VITEK 2 GN95 CARDS RESULTED IN SUSCEPTIBLE CEFTRIAXONE MICS </= 0.25 AND BMD MICS </= 0.5. VITEK 2 CARDS AND THE REFERENCE METHOD ARE IN ESSENTIAL AGREEMENT FOR BOTH STRAINS TESTED. QUALITY SYSTEMS PERFORMED A COMPLAINT SEARCH AGAINST AST-GN95 CARD LOT 6850485403, WHICH DID NOT INDICATE A TREND FOR THIS CARD LOT. ALSO, A REVIEW OF THE MOST RECENT QUARTERLY TREND REPORT, Q1 2018, DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE. IN CONCLUSION, THE VITEK 2 CARDS PERFORMED AS EXPECTED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT CEFTRIAXONE RESULTS OBTAINED ON A CAP SURVEY STRAIN (CITROBACTER BRAAKII) WHEN TESTING WITH THE VITEK® 2 AST-GN95 TEST KIT, LOT 6850485403. THE RESISTANT CEFTRIAXONE RESULT WAS OBTAINED WITH INITIAL AND REPEAT TESTING. THE EXPECTED RESULT WAS SUSCEPTIBLE. WHEN THE CUSTOMER RECEIVED THE SURVEY RESULTS, SHE TESTED WITH MICROSCAN AND OBTAINED SUSCEPTIBLE RESULTS. THE CUSTOMER DID REPEAT TESTING ON (B)(6) 2018 AND OBTAINED A SUSCEPTIBLE RESULT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736336 VITEK® 2 AST-GN95 TEST KIT VITEK® 2 AST-GN95 TEST KIT LON BIOMERIEUX, INC. 6850485403 03573026565923

    Patients

    Seq Age Sex Outcome Treatment
    1