BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM POSITIVE TEST KIT

    MDR report key: 6993319 · Received November 1, 2017

    Report

    Report Number
    1950204-2017-00360
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Report Date
    February 6, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF RECURRENT MISIDENTIFICATIONS OF ENTEROCOCCUS FAECALIS QC STRAINS AS ENTEROCOCCUS FAECIUM, IN ASSOCIATION WITH VITEK® 2 GP ID TEST KIT. AN INVESTIGATION WAS PERFORMED. THE INTENDED IDENTIFICATION TO ENTEROCOCCUS FAECALIS WAS CONFIRMED ON VITEK MS V3 (KNOWLEDGE BASE V3.0). ON VITEK 2 (V7.01) GP CARDS, ONE (1) CARD OF THE CUSTOMER LOT (CL1 : 2420434403), ONE (1) CARD OF THE CUSTOMER LOT (CL2 : 2420330113) AND ONE (1) CARD OF A RANDOM LOT (RL : 2420490403) WERE TESTED FROM CBA SUBCULTURE. ALL THREE (3) CARD LOTS GAVE AN EXCELLENT IDENTIFICATION TO E. FAECALIS. THE CUSTOMER MISIDENTIFICATION WAS NOT DUPLICATED IN-HOUSE. THE VITEK 2 GP CARD PERFORMED AS INTENDED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF RECURRENT MISIDENTIFICATION OF THEIR QC STRAIN, NCTC 12697 ENTEROCOCCUS FAECALIS, IN ASSOCIATION WITH VITEK® 2 GP ID TEST KIT (REF. 21342, LOT 2420434403). THE VITEK® 2 CARD IDENTIFIED THIS STRAIN AS ENTEROCOCCUS FAECIUM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THE QC STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773319 VITEK® 2 GRAM POSITIVE TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX INC. 2420434403 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1