BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER CLINITEK

    MDR report key: 385059 · Received March 27, 2002

    Report

    Report Number
    MW1024460
    Event Type
    Malfunction
    Date Received
    March 27, 2002
    Date of Event
    March 8, 2002
    Report Date
    March 12, 2002
    Manufacturer
    BAYER DIAGNOSTICS
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE RESULTS FOR A URINE HCG TEST USING BAYER CLINITEK HCG TEST STRIP, LOT# B0109061, EXPIRATION DATE 2/03. URINE TESTED AS POSITIVE TWICE USING LOT# V9198961. URINE TESTED NEGATIVE IN LABORATORY USING A DIFFERENT METHOD AND ALSO TESTED NEGATIVE USING A DIFFERENT LOT NUMBER OF BAYER CLINITEK HCG TEST STRIPS WHEN PERFORMED IN EMERGENCY DEPT. BAYER TECHNICAL SVS NOTIFIED. LOT# B0109061 REMOVED FROM SVC IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER CLINITEK PREGNANCY TEST STRIPS JHJ BAYER DIAGNOSTICS * B0109061

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other