BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUDS HIV-1

    MDR report key: 382093 · Received March 11, 2002

    Report

    Report Number
    1037802-2002-00002
    Event Type
    Other
    Date Received
    March 11, 2002
    Date of Event
    January 1, 2002
    Report Date
    March 8, 2002
    Manufacturer
    MUREX DIAGNOSTICS, INC.
    Product Code
    LRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE ACCOUNT REPORTED A NEGATIVE PATIENT RESULT WITH SUDS HIV1 LOT 1236. THREE WEEKS LATER, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN WITH POSITIVE RESULTS FROM SUDS HIV1 LOT 1236. BOTH SAMPLES WERE RUN ON THE SAME KIT. NO IMPACT TO PATIENT MANAGEMENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUDS HIV-1 HIV-1 ANTIBODY TEST LRM MUREX DIAGNOSTICS, INC. NA 1236

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR