BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 16569162 · Received March 17, 2023

    Report

    Report Number
    3009238284-2023-00005
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 5, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HEALGEN HAS COMPLETED THE INVESTIGATION. AFTER REVIEWING THE RELEVANT MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT NUMBER 2202049EUA, NO IRREGULARITIES WERE FOUND. TESTS RETAINED FROM LOT NUMBER 2202049EUA WERE TESTED. ALL DEVICES PERFORMED AS EXPECTED WHEN TESTED PER THE STANDARD PROCEDURE. BASED ON INVESTIGATIONS, MANUFACTURER WAS UNABLE TO REPLICATE THE CUSTOMER'S COMPLAINT. NO IRREGULARITIES OR DEVIATIONS WERE OBSERVED IN THE MANUFACTURING DOCUMENTATION FOR THE LOT RELATED TO COMPLAINT. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    MORE INFORMATION REQUESTED FROM THE CUSTOMER TO PERFORM FURTHER INVESTIGATION. CUSTOMER TOOK PCR TEST AT DOCTOR'S OFFICE. A COUPLE OF DAYS LATER, THE RESULT COME OUT AS POSITIVE. CUSTOMER PERFORMED TWO SIEMENS COVID-19 TESTS ON SAME DAY FROM SAME KIT, RESULT OF BOTH WERE NEGATIVE. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    AS HOLDERS OF THE EMERGENCY USE AUTHORIZATION, SIEMENS HEALTHCARE DIAGNOSTICS IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER HEALGEN SCIENTIFIC. THE CUSTOMER REPORTED FALSE NEGATIVE TEST RESULT FOR COVID ON CLINITEST COVID19 SELF TEST WHEN COMPARED WITH RESULT FROM PCR TEST AT DOCTOR'S OFFICE. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937362 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2202049EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female