BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST SIEMENS HEALTHINEERS

    MDR report key: 16131581 · Received January 9, 2023

    Report

    Report Number
    MW5114235
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 31, 2022
    Report Date
    January 6, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS CLINITEST COVID-19 RAPID SELF TEST HAD A MANUFACTURING DEFECT IN THE TIPS FOR THE BUFFER EXTRACTION TUBES. THERE WAS A THICK SOLID LAYER OF PLASTIC ACROSS THE NOZZLE, BLOCKING IT. I HAD TO DRILL IT OUT WITH A SEWING NEEDLE TO MAKE IT WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204960 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST SIEMENS HEALTHINEERS CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male