BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMASSE DEVICE

    MDR report key: 20323114 · Received September 26, 2024

    Report

    Report Number
    MW5160198
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 13, 2024
    Report Date
    September 23, 2024
    Manufacturer
    OPANS, LLC.
    Product Code
    OQS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A DRY BLOOD SPOT DRUG SCREENING TEST WITH OPANS AMASSE DEVICE. RESULTS WERE REPORTED TO ME AS A METHYLPHENIDATE LEVEL OF 24NG/ML WHICH IS ABOVE THERAPEUTIC RANGE (5-20) WHILE I DO NOT TAKE METHYLPHENIDATE. I KNEW ABOUT THE TEST A WEEK IN ADVANCE, SO OBVIOUSLY I DID NOT TAKE A LARGE AMOUNT OF AN UNPRESCRIBED SUBSTANCE A COUPLE HOURS BEFORE THE TEST. THIS WAS A SCREENING TEST TO END MY PROBATION WITH THE (B)(6) BOARD OF PHYSICIANS. OF HAVE BEEN WORKING VERY HARD TO MAKE SURE THAT I DID EVERYTHING PROPERLY FOR THE PAST 5 YEARS. IT HAS COST ME A HUGE AMOUNT OF MONEY INCLUDING ATTORNEY FEES. I WOULD NOT HAVE INTENTIONALLY SABOTAGED MYSELF. I AM GETTING A HAIR ANALYSIS TOMORROW. THIS AMASSE DEVICE IS NOT FDA APPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997586 AMASSE DEVICE LABORATORY DEVELOPED TEST OQS OPANS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other