BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT

    MDR report key: 7373423 · Received March 27, 2018

    Report

    Report Number
    1950204-2018-00119
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Report Date
    June 6, 2018
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    JSP
    UDI-DI
    03573026144364
    PMA / PMN Number
    K910666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE SUBMITTED PELLET FROM CUSTOMER STOCK # 585-34 (BACTEROIDES OVATUS ATCC 1296) WAS REHYDRATED AND ALONG WITH THE BIOMÉRIEUX INTERNAL QUALITY CONTROL (QC) STRAIN WERE SUBCULTURED TO COLUMBIA BLOOD AGAR (CBA). ANC CARD TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS ON CARDS FROM THE TWO CUSTOMER LOTS (2440560403, 2440541203) AND A RANDOM LOT (2440496103) IN DUPLICATE FOR EACH STRAIN. 911581 (585-34): FIVE (5) OF SIX (6) ANC CARDS TESTED SHOWED NO QC DEVIATIONS AND NO MISIDENTIFICATIONS WERE OBSERVED. FOR THE REMAINING CARD, AN ATYPICAL NEGATIVE AARA WAS DEMONSTRATED, BUT NO MISIDENTIFICATION WAS OBSERVED. 400963 (BIOMÉRIEUX INTERNAL QC STRAIN): NO QC DEVIATIONS OR MISIDENTIFICATIONS WERE OBSERVED ON ANY OF THE SIX (6) ANC CARDS TESTED. ONE (1) OF THE CUSTOMER'S REPORTED ISSUES WERE DUPLICATED WITH ONE ATYPICAL NEGATIVE AARA REACTION ON ONE (1) OF SIX (6) ANC CARDS TESTED WITH NO MISIDENTIFICATION AND WITH THE CUSTOMER'S STRAIN ONLY. VITEK® 2 CARDS PERFORMED AS EXPECTED WITH THE BIOMÉRIEUX INTERNAL QC STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION FOR BACTEROIDES OVATUS ATCC® BAA-1296¿ IN ASSOCIATION WITH THE VITEK® 2 ANC ID TEST KIT. THE ORGANISM WAS REPORTED AS BACTEROIDES STERCORIS, BACTEROIDES EGGERTHII, LOW DISCRIM PREVOTELLA ORALIS/BACTEROIDES EGGERTHII, AND PREVOTELLA ORALIS. 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 DIRECTLY ASSOCIATED WITH THE ATCC® STRAIN. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217265 VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT VITEK® 2 ANC ID CARD JSP BIOMÉRIEUX, INC. 2440560403 03573026144364

    Patients

    Seq Age Sex Outcome Treatment
    1