BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

    MDR report key: 17990063 · Received October 23, 2023

    Report

    Report Number
    MW5147281
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 23, 2023
    Manufacturer
    CELLTRION USA, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PHYSICIAN, AN ALLERGY AND IMMUNOLOGY SPECIALIST CALLED TO SUBMIT A REPORT ABOUT THE COVID-19 TEST KITS THAT ARE SUPPLIED BY THE GOVERNMENT WHICH GAVE FALSE NEGATIVE MORE THAN ONCE. THE REPORTER TOOK A TEST USING CELLTRION DIATRUST COVID-19 TEST KIT, WHICH WAS PROVIDED BY THE GOVERNMENT THAT HAS AN EXPIRATION DATE OF 1/16/2023. THE RESULT WAS NEGATIVE. THE SAME DAY, HE TOOK ANOTHER TEST USING THE CVS, FLOWFLEX COVID-19 TEST KIT AND HE GOT A POSITIVE RESULT. THE FOLLOWING DAY, HE TOOK ANOTHER TEST USING CELLTRION DIATRUST COVID-19 FOR THE SECOND TIME AND THE RESULT CAME NEGATIVE. THE SAME DAY, HE TOOK ANOTHER TEST USING THE CVS FLOWFLEX COVID-19 TEST KIT AND HE GOT ANOTHER POSITIVE TEST. HE SAID BOTH CELLTRION DIATRUST COVID-19 TEST KITS, THAT ARE SUPPLIED BY THE GOVERNMENT FAILED. HE WANTED TO KNOW HOW FDA IS HANDLING THESE SITUATIONS, SINCE THOUSANDS OF PEOPLE INCLUDING HIS PATIENTS ARE GETTING FALSE NEGATIVES AND CARING FOR OTHER IMMUNE COMPROMISED PEOPLE AND PASS THE VIRUS. REF REPORT: MW5147282.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567399 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA, INC. COVSC2002NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male