BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID -19 ANTIGEN SELF-TEST

    MDR report key: 18139473 · Received November 14, 2023

    Report

    Report Number
    MW5148124
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Report Date
    October 18, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A NEW SIEMENS COVID 4-PACK TEST KIT THROUGH THE NEW FEDERAL TEST DISTRIBUTION FROM USPS. THE KIT WAS NOT DAMAGED. BUT ALL 4 OF THE VIALS CONTAINED INSUFFICIENT FLUID TO CONDUCT A TEST. I COMPARED THE LEVEL TO A TEST I HAVE FROM GENABIO AND CONFIRMED THAT THERE WAS 1/2 OF THE REQUIRED AMOUNT OF FLUID IN THE VIALS. SO ONCE THE SWAB WAS INSERTED, THERE WAS INSUFFICIENT FLUID TO CONDUCT THE TEST. IN THE PHOTO PROVIDED, IT MAY BE DIFFICULT TO DISCERN THAT THE VIAL ON THE LEFT (SIEMENS) WAS SMALLER THAN THE ONE ON THE RIGHT AND THAT THE FLUID LEVEL WAS 1/2 OF THE AREA MARKED FOR A FULL VIAL. REFERENCE REPORT #MW5148122, #MW5148123, #MW5148125. REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237418 CLINITEST RAPID COVID -19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP SIEMENS HEALTHCARE DIAGNOSTICS INC. 2203164EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female