BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA

    MDR report key: 1202141 · Received October 16, 2008

    Report

    Report Number
    MW5008625
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 16, 2008
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TEST GIVEN - PT STATED "THE RESULTS MUST BE WRONG" - RETESTED AND WAS NEGATIVE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APTIMA NONE JJC 538447

    Patients

    Seq Age Sex Outcome Treatment
    1