BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 AST-GP67 TEST KIT

    MDR report key: 7678402 · Received July 11, 2018

    Report

    Report Number
    1950204-2018-00251
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Report Date
    September 11, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-GP67 TEST KIT (REFERENCE 22226). AN INVESTIGATION WAS PERFORMED. THE SUBMITTED CUSTOMER STRAINS WERE SUBCULTURED, AND IDENTIFICATIONS WERE CONFIRMED AS S. AUREUS. VITEK 2 AST-GP67 TESTING INCLUDED CARDS FROM THE CUSTOMER'S LOT (1320690203) AND A RANDOM LOT (1320662203) WITH VITEK 2 SOFTWARE VERSIONS 07.01 AND 08.01. ADDITIONAL TESTING INCLUDED AGAR DILUTION AS THE REFERENCE METHOD FOR OX101N, CEFOXITIN DISC DIFFUSION AS THE REFERENCE FOR OXSF101N, AND PBP2A. 911667 (L KNEE): THREE CARDS TESTED RESULTED IN OX MICS = 0.5, ONE CARD OX MIC = 1. ALL FOUR CARDS RESULTED IN NEGATIVE OXSF. REFERENCE METHODS OX AD MIC = 1 AND CEFOXITIN DISC DIFFUSION WAS RESISTANT (20 MM). PBP2A WAS POSITIVE. 911668 (R KNEE): TWO CARDS TESTED RESULTED IN OX MICS = 0.5, TWO CARDS OX MICS = 1. ALL FOUR CARDS RESULTED IN NEGATIVE OXSF. REFERENCE METHODS OX AD MIC = 1 AND CEFOXITIN DISC DIFFUSION WAS RESISTANT (20 MM). PBP2A WAS POSITIVE. 911669 (BLOOD): THREE CARDS TESTED RESULTED IN OX MICS = 0.5, ONE CARD OX MIC = 1. ALL FOUR CARDS RESULTED IN NEGATIVE OXSF. REFERENCE METHODS OX AD MIC = 1 AND CEFOXITIN DISC DIFFUSION WAS RESISTANT (20 MM). PBP2A WAS POSITIVE. VITEK 2 OXACILLIN MICS ARE IN ESSENTIAL AGREEMENT WITH THE REFERENCE METHOD WHILE THE CEFOXITIN SCREEN TEST AND REFERENCE METHOD ARE NOT IN AGREEMENT LEADING TO THE NON-DETECTION OF THE MRSA STRAIN FOR THIS PATIENT'S ISOLATES. (V07.01 AND V08.01) THE ISOLATES EXHIBIT ATYPICAL GROWTH BEHAVIOR. THE INVESTIGATION CONCLUDED THE VITEK 2 AST-GP67 TEST KIT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 AST-GP67 TEST KIT (REFERENCE 22226). THE CUSTOMER REPORTED THE VITEK CARD RESULT WAS STAPH AUREUS OXACILLIN SENSITIVE AND THE BIOFIRE DETECTED MECA, AND THE PBP2A DETECTED MECA. THE CUSTOMER REPEATED THE ISOLATE TESTING AND THE RESULT WAS SUSCEPTIBLE. THE ISOLATE WAS SENT TO THE MAYO CLINIC AND THE TEST RESULT WAS SUSCEPTIBLE. THE CUSTOMER REPORTED OUT THE ISOLATE AS MRSA TO PREVENT THERAPEUTIC FAILURE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519923 VITEK®2 AST-GP67 TEST KIT VITEK®2 AST-GP67 TEST KIT LON BIOMERIEUX, INC 1320690203 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1