BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 488754 · Received September 29, 2003

    Report

    Report Number
    MW1029662
    Event Type
    Malfunction
    Date Received
    September 29, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 29, 2003
    Manufacturer
    ABBOTT LABS
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAS HAD RAPID STREP TEST 4-5 TIMES IN THE PAST SEVERAL MONTHS AND THEY HAVE BEEN POSITIVE. THE LAST 2 TIMES, A THROAT CULTURE HAS BEEN DONE ON THE SAME DAY AND HAVE BOTH BEEN NEGATIVE. PT HAS BEEN ON SEVERAL ANTBIOTICS WITH OUTBREAK OF HIVES. POSSIBLE FALSE POSITIVE RESULTS ON RAPID STREP TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT RAPID STREP TEST GTY ABBOTT LABS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR