BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN70 TEST KIT

    MDR report key: 7732828 · Received July 30, 2018

    Report

    Report Number
    1950204-2018-00275
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Report Date
    September 16, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026398477
    PMA / PMN Number
    K152075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED FOR THE REPORTED FALSE SUSCEPTIBLE ERTAPENEM (ETP) RESULTS FOR TWO KLEBSIELLA PNEUMONIAE STRAINS FROM ONE PATIENT, IN ASSOCIATION WITH THE VITEK® 2 AST-GN70 TEST KIT (LOT 5900705403). THE CUSTOMER'S TWO SUBMITTED STRAINS WERE SUBCULTURED, AND IDENTIFICATIONS OF KLEBSIELLA PNEUMONIAE WERE CONFIRMED. TESTING INCLUDED AST-GN70 CARDS FROM THE CUSTOMER LOT (5900705403) AND A RANDOM LOT (5900650403) ,AS WELL AS AGAR DILUTION (AD) AS THE REFERENCE METHOD FOR THE ETP01N FORMULATION USED IN THIS CARD. ETP BREAKPOINTS: </=0.5 (S) ,1 (I), >/=2 (R). STRAIN 911676 (K. PNEUMONIAE #1): FOR ONE CARD ETP MICS = 1 WITH AES MODIFICATION TO RESISTANT DUE TO IMPERMEABILITY CARBAPENEMASE PHENOTYPE DETECTED. THIS CARD IS AN ESSENTIAL AGREEMENT ERROR WITH THE REFERENCE WITH A MINOR ERROR OF CATEGORY. FOR THE SECOND CARD ETP MIC = 2. ETP (SAME PHENOTYPE DETECTED). ETP REFERENCE AD MIC = 4. THIS CARD IS IN ESSENTIAL AGREEMENT WITH THE REFERENCE METHOD. STRAIN 911677 (K. PNEUMONIAE #2): BOTH CARDS TESTED RESULTED IN ETP MIC = 2 WITH THE SAME IMPERMEABILITY CARBAPENEMASE PHENOTYPE DETECTED. ETP REFERENCE AD MIC = 4. VITEK 2 CARDS AND REFERENCE METHOD ARE IN ESSENTIAL AGREEMENT. THE CUSTOMER'S REPORTED FALSE SUSCEPTIBILITY WAS NOT DUPLICATED. VITEK 2 CARDS ARE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED FALSE SUSCEPTIBLE ERTAPENEM RESULTS FOR TWO KLEBSIELLA PNEUMONIAE STRAINS FROM ONE PATIENT, IN ASSOCIATION WITH THE VITEK® 2 AST-GN70 TEST KIT (LOT 5900705403). THE CUSTOMER REPORTED THAT THE ERTAPENEM WAS SUSCEPTIBLE WITH INITIAL TESTING (MIC= <=0.5). UPON REPEAT TESTING ERTAPENEM TESTED RESISTANT (MIC=2 WITH NEW LOWERED CARBAPENEM BREAKPOINTS). ERTAPENEM DISC TESTING WAS RESISTANT WITH ZONE SIZE OF 15 MM. 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
    573133 VITEK® 2 AST-GN70 TEST KIT VITEK® 2 AST-GN70 TEST KIT LON BIOMERIEUX, INC 5900705403 03573026398477

    Patients

    Seq Age Sex Outcome Treatment
    1