BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUDS HIV-1

    MDR report key: 299559 · Received October 4, 2000

    Report

    Report Number
    1037802-2000-00004
    Event Type
    Other
    Date Received
    October 4, 2000
    Date of Event
    August 18, 2000
    Report Date
    September 29, 2000
    Manufacturer
    MUREX DIAGNOSTICS
    Product Code
    LRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2000 THE ACCOUNT REPORTED A REPEAT REACTIVE (1+) SUDS HIV RESULT ON A RELATIVE. BASED ON THE POSITIVE RESULT THE INFANT WAS GIVEN AZT THERAPY. THE SAMPLE WAS SENT FOR WESTERN BLOT TESTING WHICH CAME BACK NEGATIVE. THE AZT THERAPY WAS DISCONTINUED AFTER THE RECEIPT OF THE WESTERN BLOT RESULTS. ACCOUNT WAS NOT AWARE OF ANY ADVERSE REACTION TO THE AZT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUDS HIV-1 HIV-1 ANTIBODY TEST LRM MUREX DIAGNOSTICS NA 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY