BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAIR OF ABUSE DRUG TEST LDT

    MDR report key: 18858211 · Received March 6, 2024

    Report

    Report Number
    MW5152465
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 5, 2024
    Manufacturer
    QUEST DIAGNOSTICS
    Product Code
    OQS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 5/23/2024 FOR REPORT MW5152465 TO UPDATE MANUFACTURER.

    Description of Event or Problem · 0

    I TOOK A HAIR TEST COLLECTED IN (B)(6) AND SENT TO KANSAS LAB- QUEST DIAGNOSTICS. ON THE LABS WEBSITE IT STATES CUTOFF WAS 500PG AND CONFIRMATION 500PG. THE TEST I TOOK WAS INITIAL CUTOFF 500PG AND CONFIRMATION 250PG. ADDITIONALLY THE CHAIN OF CUSTODY WAS INACCURATE AS THE TEST HAS NO COLLECTION TIME AND THEIR IS NO SHIPPING AND TRANSPORT INFORMATION. THESE TESTS NEED TO BE REGULATED OR TAKEN OFF THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160796 HAIR OF ABUSE DRUG TEST LDT LABORATORY DEVELOPED TEST OQS QUEST DIAGNOSTICS 37004N

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other ADDERALL .| MUCINEX D.| TAMIFLU.