BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUEST LABS HAIR DRUG TEST 37000N

    MDR report key: 18204895 · Received November 22, 2023

    Report

    Report Number
    MW5148457
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    September 18, 2021
    Report Date
    November 20, 2023
    Manufacturer
    QUEST PRODUCTS, INC.
    Product Code
    DKZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT TOOK A HAIR DRUG OF ABUSE TEST. RESULTS WERE POSITIVE FOR "METHAMPHETAMINE" PATIENT WAS PRESCRIBED MEDICATIONS THAT ARE KNOWN TO CROSS REACT WITH THE TEST. THE TESTS WAS REVIEWED BY A MRO (MEDICAL REVIEW OFFICER) AND FOUND POSITIVE. MRO DID NOT ALLOW FOR A RETEST AND IN FACT WAS MADE AWARE OF EVENTS THAT SHOULD HAVE CANCELLED THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272032 QUEST LABS HAIR DRUG TEST 37000N ENZYME IMMUNOASSAY, AMPHETAMINE DKZ QUEST PRODUCTS, INC. 37000N

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other