BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAQUICK ADVANCE HIV-1/2 RAPID ANTIBODY TEST

    MDR report key: 3080356 · Received April 22, 2013

    Report

    Report Number
    MW5029917
    Event Type
    Other
    Date Received
    April 22, 2013
    Date of Event
    April 18, 1989
    Report Date
    April 22, 2013
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    MZF
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A ROUTINE SERUM (B)(6), WHICH WAS REPEATEDLY (B)(6), WITH A STRONGLY (B)(6) WESTERN BLOT. I HAD HIM RETURN FOR REPEAT TESTING TO MAKE SURE IT WAS NOT AN ERROR WITH SPECIMEN MIX-UP. I DID AN ORAQUICK TEST AT THE TIME. THE ORAQUICK WAS (B)(6). THE REPEAT SERUM TESTING ON THE SPECIMEN THE SECOND VISIT WAS AGAIN STRONGLY (B)(6). DATE OF USE: (B)(6) 2013. REASON FOR USE: SCREENING/CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173165 ORAQUICK ADVANCE HIV-1/2 RAPID ANTIBODY TEST ORAQUICK ADVANCE HIV-1/2 RAPID ANTIBODY TEST MZF ORASURE TECHNOLOGIES, INC 6631849

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other