BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 16956269 · Received May 18, 2023

    Report

    Report Number
    3009238284-2023-00011
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 15, 2023
    Manufacturer
    HEALGEN SCIENTIFIC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 2202139EUA, NO IRREGULARITIES WERE FOUND. TESTS RETAINED FROM LOT NUMBER 2202139EUA 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 RESULT OF WHICH CAME OUT POSITIVE. TO VERIFY POSITIVE RESULT OF PCR TEST, CUSTOMER RETESTED WITH SIEMENS CLINITEST COVID-19 SELF TEST, EACH DAY FOR 4 DAYS. RESULT OF ALL COVID-19 TESTS CAME OUT NEGATIVE. CUSTOMER ALSO TESTED WITH TWO DIFFERENT NON-SIEMENS COVID-19 TESTS, THE RESULT OF WHICH ALSO CAME OUT AS 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 LLC. 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
    1906789 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC 2202139EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown