BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM POSITIVE TEST KIT

    MDR report key: 7100845 · Received December 8, 2017

    Report

    Report Number
    1950204-2017-00438
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Report Date
    April 11, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF ENTEROCOCCUS CASSELIFLAVUS AS ENTEROCOCCUS GALLINARUM WITH THE VITEK® 2 GP ID TEST KIT (REF 21342), LOT 2420386103. THE CUSTOMER'S STRAIN WAS NOT SUBMITTED FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE INTERNAL BIOMÉRIEUX QC STRAIN WAS SUBCULTURED TO REMEL TSAB MEDIA. TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH VITEK GP CARDS FROM THE CUSTOMER'S LOT AND FROM A RANDOM LOT, IN DUPLICATE. ALL FOUR (4) GP CARDS GAVE THE EXPECTED POSITIVE BGAR REACTIONS. NO QC DEVIATIONS OR MISIDENTIFICATIONS WERE OBSERVED. THE VITEK 2 GP CARDS PERFORMED AS EXPECTED FOR THIS STRAIN WHEN THE RECOMMENDED TSAB MEDIA IS USED. THE VITEK2 GP LOT 2420386103 MET FINAL QC RELEASE CRITERIA AND PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT IN ASSOCIATION WITH VITEK® 2 GP ID TEST KIT (REF 21342), LOT 2420386103. VITEK® 2 IDENTIFIED QC STRAIN, ATCC700327 ENTEROCOCCUS CASSELIFLAVUS, AS ENTEROCOCCUS GALLINARUM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879696 VITEK® 2 GRAM POSITIVE TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX INC. 2420386103 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1