BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME ACCESS HIV-1 TEST SYSTEM

    MDR report key: 187335 · Received September 15, 1998

    Report

    Report Number
    59529-1998-90001
    Event Type
    Malfunction
    Date Received
    September 15, 1998
    Date of Event
    August 9, 1998
    Report Date
    September 9, 1998
    Manufacturer
    HOME ACCESS HEALTH CORPORATION
    Product Code
    DDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CLIENT TESTED NEGATIVE WITH HOME ACCESS HIV-1 TEST SYSTEM ON 8/7/98. CLIENT REPORTED TESTING POSITIVE FOR HIV IN 11/95. CLIENT REPORTED THAT HE HAS BEEN TREATED BY A PHYSICIAN BUT THE PHYSICIAN DID NOT TEST HIM PRIOR TO TREATMENT FOR HIV. CLIENT REFUSED TO BREAK ANONYMITY OR PROVIDE RELEASE TO OBTAIN MEDICAL RECORDS SO PREVIOUS TEST RESULTS COULD BE VERIFIED. REVIEW OF HAH LAB RESULTS, (EIA) VERIFIED NEGATIVE. UNABLE TO VERIFY CLIENTS CLAIM OF PREVIOUS POSITIVE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME ACCESS HIV-1 TEST SYSTEM HIV-1 ANTIBODY DETECTION SYSTEM DDQ HOME ACCESS HEALTH CORPORATION * 982104

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other 3 DIFFERENT HIV MEDICATIONS