BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUEST LABS AMPHETAMINE HAIR TEST

    MDR report key: 16684131 · Received April 4, 2023

    Report

    Report Number
    MW5116362
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    July 23, 2020
    Report Date
    April 4, 2023
    Manufacturer
    QUEST PRODUCTS, INC
    Product Code
    DKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT INACCURATE RESULTS FROM A QUEST AMPHETAMINE HAIR TEST. PATIENT STATED THAT SHE WAS TAKING VYVANSE, WELLBUTRIN, AND BROMFED COUGH MEDICINE AT THE TIME OF THE TEST, WHICH SHOULD NOT TRIGGER A POSITIVE RESULT. PATIENT SAID HER TEST CAME BACK 90% POSITIVE FOR METHAMPHETAMINE EVEN THOUGH SHE HAS NEVER USED IT. PATIENT STATED SHE WAS TOLD HER MEDICATIONS WERE NOT THE CAUSE. PATIENT STATED THE TEST WAS NOT ACCURATE AND DOES NOT BELIEVE THE TESTS ARE RUN PROPERLY. PATIENT MENTIONED THAT BROMFED CONTAINS PSEUDOEPHEDRINE. PATIENT ALSO STATED SHE RECEIVED A 192-PAGE DOCUMENT PACKAGE IN (B)(6) 2022 IN REFERENCE TO THE QUEST HAIR TEST WHICH STATED CORRECTIVE ACTIONS WERE NEEDED WITH HER TEST SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416107 QUEST LABS AMPHETAMINE HAIR TEST ENZYME IMMUNOASSAY, AMPHETAMINE DKZ QUEST PRODUCTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female