BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN09 TEST KIT

    MDR report key: 7849053 · Received September 5, 2018

    Report

    Report Number
    1950204-2018-00334
    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 911689: ONE CUSTOMER LOT (1060543103) OF AST-GN09 CARDS GAVE AN MIC<=1; THE SECOND CUSTOMER LOT (1060699203) AND THE RANDOM LOT OF AST-GN09 CARDS GAVE MICS=2. FOR THIS LOT OF AST-GN09 CARD, WHICH GAVE A FEP MIC<=1, CARD AND REFERENCE METHOD RESULTS ARE MORE THAN ONE DOUBLING DILUTION APART, WHICH IS AN ESSENTIAL AGREEMENT ERROR FOR THE VITEK 2. IN SUMMARY: FOR THE FIFTH ISOLATE (911689), THIS STRAIN IS ATYPICAL AND EXHIBITED ESSENTIAL AGREEMENT ERRORS COMPARED TO REFERENCE METHOD WITH THE VITEK 2 AST-GN09 CARD FOR THIS LOT (LOT 1060543103).

    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 1060543103). 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) BIOMERIEUX AND FURTHER TESTING WAS PERFORMED. THE STRAINS WERE TESTED USING THE VITEK 2 AST-GN09 ((B)(4)) AND AST-N334 ((B)(4)) 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
    689288 VITEK® 2 AST-GN09 TEST KIT VITEK® 2 AST-GN09 TEST KIT LON BIOMERIEUX, INC. 1060543103

    Patients

    Seq Age Sex Outcome Treatment
    1