BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONFIDE HIV TESTING SERVICE

    MDR report key: 99752 · Received June 19, 1997

    Report

    Report Number
    2248203-1997-00007
    Event Type
    Other
    Date Received
    June 19, 1997
    Date of Event
    June 2, 1997
    Report Date
    June 19, 1997
    Manufacturer
    DIRECT ACCESS DIAGNOSTICS
    Product Code
    LRM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ALLEGED FALSE NEGATIVE RESULT. THE CALLER ALLEGES SHE TESTED POSITIVE FOR HIV ANTIBODIES THREE TIMES AT AN ANONYMOUS "OPEN DOOR" CLINIC APPROXIMATELY EIGHT MONTHS AGO AND RECENTLY TESTED NEGATIVE WITH CONFIDE. WHEN QUESTIONED BY THE CONFIDE COUNSELOR, THE CLIENT SAID SHE HAD NO PROBLEM COLLECTING A BLOOD SAMPLE AND HAD MAILED THE TEST CARD THE VERY NEXT DAY. THE CLIENT WAS ADVISED BY THE CONFIDE COUNSELOR TO SEEK FOLLOW-UP MEDICAL EVALUATION. UPON LEARNING OF THIS COMPLAINT, DAD QUALITY ASSURANCE MET WITH THE APPROPRIATE DAD DEPARTMENTS AND LAUNCHED COMPLAINT INVESTIGATION QAC#97-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDE HIV TESTING SERVICE HOME BLOOD COLLECT/HIVAB LAB TEST/ANONYM. PHONE RPT/COUNSEL LRM DIRECT ACCESS DIAGNOSTICS * 26E012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other