BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORAQUICK IN HOME HIV TEST

    MDR report key: 3074397 · Received April 19, 2013

    Report

    Report Number
    3004142665-2013-00002
    Event Type
    Death
    Date Received
    April 19, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    MVZ
    PMA / PMN Number
    BP120001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE ANONYMOUS, CONFIDENTIAL DESIGN OF THE CALL CENTER OPERATIONS, WE ARE UNABLE TO VERIFY THE INFORMATION PROVIDED BY THE CALLER OR PERFORM ANY ADDITIONAL INVESTIGATION CONCERNING THIS MATTER. WE CONSIDER THIS REPORT TO BE COMPLETE.

    Description of Event or Problem · 1

    ORASURE'S CONSUMER CALL CENTER (OPERATED BY (B)(6)) RECEIVED AN ANONYMOUS CALL AT 17:38 ON (B)(6) 2013, FROM A MAN INQUIRING ABOUT INTERPRETATION OF RESULTS FROM A TEST STICK THAT WAS ALLEGEDLY FOUND IN HIS ROOMMATE'S BATHROOM. THE CALLER DID NOT KNOW HOW THE TEST WAS PERFORMED OR SPECIFICALLY WHEN THE TEST HAD BEEN TAKEN. THE CALLER WANTED TO KNOW IF THE CALL CENTER OPERATOR COULD INTERPRET THE TEST RESULT. THE OPERATOR INFORMED THE CALLER THAT THE TEST RESULT IS ONLY VALID FOR 40 MINUTES AND THEREFORE COULD NOT BE INTERPRETED AFTER THAT TIME. THE CALLER STATED THAT HIS ROOMMATE HAD COMMITTED SUICIDE AND THAT HE WAS TRYING TO UNDERSTAND THE REASONS SURROUNDING HIS DEATH (AND IF THE RESULTS COULD HAVE HAD ANY ROLE IN HIS DECISION TO COMMIT SUICIDE). THE OPERATOR RECOMMENDED A SUICIDE HOTLINE TO DISCUSS HIS QUESTIONS WITH TRAINED COUNSELORS AS TO WHY HIS FRIEND MAY HAVE TAKEN HIS LIFE. THE CALLER INDICATED THE HE DID NOT WANT THE HOTLINE CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169599 ORAQUICK IN HOME HIV TEST ORAQUICK IN HOME HIV TEST (PR CODE MVZ) MVZ ORASURE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death