BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11916121 · Received June 1, 2021

    Report

    Report Number
    9615754-2021-00171
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    INTENDED USE: THE VITEK® MS SYSTEM, REFERENCE 410895, IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: BTF PTY LTD, A BIOMÉRIEUX COMPANY IN (B)(6), NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT RESULTS BETWEEN BRUKER MALDI-TOF (ENTEROBACTER CLOACAE) AND VITEK MS, REF 410895 (ENTEROBACTER HORMAECHEI). BTF PTY LTD REPORTED HAVING RECEIVED A STRAIN FROM (B)(6), IDENTIFIED AS ENTEROBACTER CLOACAE BY BRUKER SYSTEM. ONCE RECEIVED BY THE COMPANY, THE STRAIN WAS TESTED WITH THE VITEK MS SYSTEM. AN ORGANISM IDENTIFICATION TO ENTEROBACTER HORMAECHEI (99.9%) WAS OBTAINED. REPEAT TESTING VIA VITEK MS WAS PERFORMED ON FOUR (4) SWABS FROM THE (B)(6) CUSTOMER : ALL RESULTS WERE ENTEROBACTER HORMAECHEI. A VITEK MS FINE-TUNING WAS PERFORMED, AND SAMPLES WERE RE-TESTED. THE IDENTIFICATIONS OBTAINED REMAINED ENTEROBACTER HORMAECHEI AT 99.9%. NO PATIENT IMPACT HAS BEEN REPORTED AS A CONSEQUENCE OF THE DISCREPANT RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807936 VITEK MS INSTRUMENT VITEK MS INSTRUMENT QBN BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1