BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORAQUICK IN HOME HIV TEST

    MDR report key: 2077543 · Received April 27, 2011

    Report

    Report Number
    2528909-2011-00001
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO THE MANUFACTURER BY THE USER FACILITY AS A SERIOUS ADVERSE EVENT - NOT RELATED TO DEVICE. SUBJECT PARTICIPATED IN CLINICAL TRIAL (B)(4): "A MULTI-CENTER, ACTUAL USE CLINICAL TRIAL OF THE ORAQUICK ADVANCE (B)(6) ANTIBODY TEST OVER-THE-COUNTER (OTC) PRODUCT PERFORMANCE IN UNTRAINED USERS". SUBJECT SIGNED CONSENT AND WAS ENROLLED IN THE TRIAL ON (B)(6) 2011. AT THIS VISIT, VENIPUNCTURE BLOOD WAS COLLECTED FOR LABORATORY TESTING FOR (B)(6). SUBJECT RETURNED TO THE SITE FOR VISIT 2 ON (B)(6) 2011 AT WHICH TIME THE ORAQUICK IN HOME IV TEST KIT WAS DISPENSED TO THE SUBJECT TO TAKE HOME AND PERFORM SELF-TESTING IN A SETTING OF HER CHOOSING. SUBJECT WAS SCHEDULED TO RETURN FOR VISIT 3 ON (B)(6) 2011 TO REVIEW HER SELF-TEST RESULTS AND LABORATORY RESULTS FROM BLOOD COLLECT AT VISIT 1. THE SUBJECT WAS A NO-SHOW FOR THIS VISIT. ON (B)(6) 2011, SUBJECT WAS REPORTED FOUND HUFFING COMPUTER CLEANER BY SPRAYING IT ON HER SLEEVE AND INHALING ALONG WITH SPRAYING IT IN HER MOUTH. THE SUBJECT WAS FOUND COHERENT AND TALKING AND WAS TRANSPORTED TO (B)(6) HOSPITAL WHERE SHE LATER DIED. IT IS UNK IF SHE PERFORMED THE SELF-TEST. HER (B)(6) LABORATORY TEST RESULTS WERE (B)(6) NEGATIVE (UTILIZING AN FDA APPROVED IVD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAQUICK IN HOME HIV TEST ORAQUICK IN HOME HIV TEST MZF ORASURE TECHNOLOGIES, INC. 10083C

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR