BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE

    MDR report key: 930574 · Received October 17, 2007

    Report

    Report Number
    MW5004137
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 17, 2007
    Manufacturer
    AMNISURE INTERNATIONAL LLC
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE REC'D A RECALL FROM THE MFR OF AMNISURE ROM TESTING DEVICES. AFTER REVIEW OF THE RECALL DATA, IT IS MY CONCERN THAT THE TEST NO LONGER FALLS INTO "WAIVED CATEGORY" DEFINITIONS. DILUTIONS OF THE SPECIMEN AT THE BEDSIDE IS NEITHER PRACTICAL OR WITHIN THE SCOPE OF PRACTICE FOR MOST OF THE PERSONNEL THAT WOULD BE PERFORMING THE TEST. ALSO, THE DATA IN THE RECALL DESCRIBING THE SO CALLED "HOOK EFFECT" IS DEFINITELY OUT OF THE AREA OF EXPERTISE FOR MOST OF THE WOULD BE TESTING PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMNISURE AMNISURE ROM TEST NQM AMNISURE INTERNATIONAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR