BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 GP TEST KIT

    MDR report key: 7694062 · Received July 17, 2018

    Report

    Report Number
    1950204-2018-00258
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQM
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS INITIATED DUE TO A MISIDENTIFICATION TO GLOBICATELLA SANGUINIS (96%) FOR A CTCB STRAIN OF ACTINOTIGNUM SCHAALII (CTCB 1811) ON VITEK® 2 V7.01 GP ID CARDS. THE CUSTOMER STRAIN WAS NO LONGER AVAILABLE TO SUBMIT FOR EVALUATION .TESTING WAS PERFORMED ON AN INTERNAL REFERENCE STRAIN. ON VITEK 2 (V7.01), TESTS PERFORMED FROM ISOLATE SUBCULTURED ON PVX WITH CO2 ATMOSPHERE. TWO LOTS OF GP ID CARDS WERE TESTED WITH THE INTERNAL REFERENCE STRAIN : CUSTOMER LOT 2420551103 (CL), AND A RANDOM LOT 2420617403 (RL) WITH THE FOLLOWING RESULTS: UNIDENTIFIED ORGANISM WITH CL LOT AND GARDNERELLA VAGINALIS (93%) WITH RL LOT; HOWEVER, THE SPECIES ACTINOTIGNUM SCHAALII IS NOT PRESENT IN THE GP ID KNOWLEDGE BASE (KB). IDENTIFICATION WITH VITEK MS CONFIRMED THE IDENTIFICATION TO ACTINOTIGNUM SCHAALII (99.9%). THERE IS A LIMITATION FOR SPECIES NOT CLAIMED IN THE KB : TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. GP ID CARDS PERFORM AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION ASSOCIATED WITH VITEK® GP TEST KIT (REFERENCE 21342). THE CUSTOMER REPORTED OBSERVING AN INCORRECT IDENTIFICATION OF GLOBICATELLA SANGUINIS FOR AN ACTINOTIGNUM SCHAALII EEQ CTCB SURVEY STRAIN. THE STRAIN WAS TESTED ON THREE (3) DIFFERENT AGAR PLATES: CNA (PRESENCE OF COLONIES), CHOCOLATE (PRESENCE OF COLONIES), CPS (ABSENCE OF COLONIES). THE CUSTOMER REPORTED NOT PERFORMING ROUTINE QUALITY CONTROL CHECKS. A GRAM STAIN WAS PERFORMED PRIOR TO CARD SET UP AND FOUND GRAM-POSITIVE COCCI AND CATALASE NEGATIVE. AS INDICATED IN THE CTCB SURVEY INSTRUCTIONS ACTINOTIGNUM SCHAALII IS A "SHORT BACILLUS, ALMOST COCCI-LIKE" WHICH COULD EXPLAIN THE "COCCI GRAM +" RESULT AND CONSEQUENTLY THE CHOICE OF THE GP ID CARD. THIS ORGANISM SHOULD BE TESTED WITH THE VITEK 2 ANC TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE EEQ SURVEY STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537720 VITEK®2 GP TEST KIT VITEK®2 GP TEST KIT LQM BIOMERIEUX, INC 2420551103 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1