BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 7215406 · Received January 24, 2018

    Report

    Report Number
    1950204-2018-00043
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Report Date
    May 21, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO A CUSTOMER NOTIFICATION OF A MISIDENTIFICATION OF AN AEROCOCCUS SANGUINICOLA STRAIN ON VITEK® 2 (V7.01) GP ID TEST KIT (REF 21342). THE REFERENCE METHOD (SEQUENCING FULL 16S) USED TO DETERMINE THE INTENDED RESULT, GIVES AN EXCELLENT IDENTIFICATION TO THE SPECIES A. SANGUINICOLA (99.83%). ON VITEK 2 (V7.01) GP CARDS, ONE (1) CARD OF THE CUSTOMER LOT (2420462203 CALLED CL) AND ONE (1) CARD OF A RANDOM LOT (2420490403 CALLED RL), FROM CPSE & PVX WERE TESTED. VITEK 2 GAVE: FROM CPSE : -ACCEPTABLE IDENTIFICATION TO THE SPECIES GEMELLA HAEMOLYSANS (85%) ON CL -EXCELLENT IDENTIFICATION TO THE SPECIES AEROCOCCUS VIRIDANS (97%) ON RL FROM PVX : -ACCEPTABLE IDENTIFICATION TO THE SPECIES ALLOIOCOCCUS OTITIS (89%) ON CL -GOOD IDENTIFICATION TO THE SPECIES AEROCOCCUS VIRIDANS (92%) ON RL THE CUSTOMER MISIDENTIFICATIONS WERE DUPLICATED IN HOUSE. THE SPECIES A. SANGUINICOLA IS NOT INCLUDED IN THE VITEK 2 V7.01 GP CARD KNOWLEDGE BASE. THERE IS A LIMITATION FOR SPECIES NOT CLAIMED IN THE KNOWLEDGE BASE : TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF AEROOCOCCUS SPECIES AS GRANULICATELLA ADIACENS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. TESTING VIA MASS SPECTOMETRY OBTAINED THE AEROCOCCUS RESULT. THE CUSTOMER INDICATED THERE WAS NO ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH DUE TO THE DISCREPANT VITEK® 2 GP ID RESULT. 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
    60247 VITEK® 2 GRAM POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID TEST KIT LQL BIOMERIEUX INC. 2420462203 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1