BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)

    MDR report key: 17078479 · Received June 6, 2023

    Report

    Report Number
    MW5118209
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 3, 2023
    Manufacturer
    SIEMENS / HEALGEN SCIENTIFIC LLC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE AN UNEXPIRED SIEMENS/HEALGEN SCIENTIFIC CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) WHERE THERE IS NONE OR NOT ENOUGH LIQUID IN ANY OF THE SEALED TUBES AND THEREFORE CANNOT USE THEM. (LOT 2202069EUA). PRINTED EXPIRATION DATE IS 2022-12, BUT IT WAS EXTENDED TO 2024-01 ON THE FDA EUA WEBSITE (HTTPS://WWW.FDA.GOV/MEDIA/162503/DOWNLOAD). REFERENCE REPORTS: MW5118210, MW5118211, MW5118212, MW5118213.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330084 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP SIEMENS / HEALGEN SCIENTIFIC LLC. 2202069EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male