BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTINGEN SELF-TEST

    MDR report key: 16673306 · Received April 3, 2023

    Report

    Report Number
    MW5116233
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 31, 2023
    Report Date
    March 31, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BOX OF PHYSICALLY DEFECTIVE HEALGEN SCIENTIFIC LLC CLINITEST RAPID COVID ANTIGEN SELF-TEST DISTRIBUTED BY SIEMENS HEALTHINEERS. LOT 2204623EUA, REF (B)(4). TWO OR THREE OF THE PLASTIC TIPS THAT GO ON THE TUBE TURNED OUT TO BE CLOSED AND WOULD NOT ALLOW THE LIQUID + PRODUCTS OF SWABBING TO DRIP OUT. AS PRESSURE WAS INCREASED, THE FIRST TUBE BEGAN INSTEAD FOAMING UP AND OUT OF THE JUNCTION BETWEEN THE TIP AND THE TUBE. WE TRIED AGAIN WITH A SECOND TIP. IT DID EVENTUALLY ALLOW THE LIQUID OUT, BUT IN A MASSIVE SPLOOSH THAT PROBABLY INVALIDATED THE RESULT, GOT ALL OVER MY HANDS AND ONTO THE ONE REMAINING TESTING BAR. NOT IDEAL FOR OUR HOUSEHOLD DEVELOPING POTENTIAL COVID SYMPTOMS. REFERENCE REPORT MW5116232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144547 CLINITEST RAPID COVID-19 ANTINGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC LLC. 2204623EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male