BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMASSE BLOOD TEST

    MDR report key: 16993998 · Received May 23, 2023

    Report

    Report Number
    MW5117791
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 28, 2023
    Report Date
    May 19, 2023
    Manufacturer
    OPANS, LLC.
    Product Code
    PRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD THE STICK BLOOD TEST DONE AND IT SHOWED AS POSITIVE WHEN IN FACT I HAVE NOT USED, SO STATING THESE DEVICES ARE FAULTY AND NEED TOOK OF THE MARKET. MY OPINION JUST STAY USING A REG BLOOD DRAWN TEST AT HOSPITAL, IT'S MORE ACCURATE. AND BECAUSE THIS HAPPENED TO ME, IT CAUSED AN ISSUE WITH CPS (CHILD PROTECTIVE SERVICES) AND SO FOR THAT I DON'T GET TO SEE MY CHILD NOW. PLEASE HELP ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650301 AMASSE BLOOD TEST CAPILLARY BLOOD COLLECTION DEVICE FOR ALTERNATIVE SITE COLLECTION PRJ OPANS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other SUBOXONE | WELLBUTRIN