BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMASSE BIO-FLUID DETECTION DEVICE

    MDR report key: 21719121 · Received March 28, 2025

    Report

    Report Number
    MW5168336
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 27, 2025
    Manufacturer
    OPANS, LLC.
    Product Code
    OQS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED REGARDING A TEST HER HUSBAND TOOK FOR A TOXICOLOGY REPORT. ON (B)(6) 2025 HE HAD A URINE SCREEN DONE WHICH CAME BACK NEGATIVE AND ALSO HAD A BLOOD SCREEN DONE THE SAME DAY AND THAT CAME BACK POSITIVE FOR METHAMPHETAMINE. THE WIFE STATED HE HAS NOT USED DRUGS IN 6 MONTHS AND DOES NOT UNDERSTAND WHY THE BLOOD SCREEN CAME BACK POSITIVE IF THE URINE SCREEN IS NEGATIVE. THIS FALSE POSITIVE RESULT HAS CAUSED THE REPORTER'S HUSBAND TO BE IMPRISONED. THE WIFE STATES THE TEST IS NOT FDA APPROVED AND THIS SHOULD BE ILLEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713334 AMASSE BIO-FLUID DETECTION DEVICE LABORATORY DEVELOPED TEST OQS OPANS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male