BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE

    MDR report key: 2225297 · Received August 22, 2011

    Report

    Report Number
    2225297
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 22, 2011
    Manufacturer
    AMNISURE INTERNATIONAL
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN AMNISURE TEST WAS OPENED TO BE USED ON A PATIENT, AND THE TEST VIAL WAS FOUND TO BE DRY. TEST CAN NOT BE PERFORMED WITHOUT A VIAL WITH SOLVENT THAT EXTRACTS THE SAMPLE SUBSTANCE FROM THE SWAB.====================== MANUFACTURER RESPONSE FOR AMNISURE TEST, AMNISURE (PER SITE REPORTER)======================VENDOR PROVIDED ADDITIONAL AMNISURE TEST KITS AT NO EXPENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMNISURE AMNISURE TEST NQM AMNISURE INTERNATIONAL * A10012012/12

    Patients

    Seq Age Sex Outcome Treatment
    1 *