BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 16133974 · Received January 10, 2023

    Report

    Report Number
    3009238284-2023-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 16, 2022
    Report Date
    February 14, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MORE INFORMATION WAS REQUESTED FROM THE CUSTOMER TO PERFORM FURTHER INVESTIGATION, TWO TESTS EACH ON CUSTOMER AND SPOUSE WERE POSITIVE. TEST RESULT AT DOCTOR'S OFFICE WITH AN UNKNOWN TEST WERE NEGATIVE. DOCTOR'S OFFICE DIAGNOSED THEM WITH COMMON COLD. ALSO NOT KNOWN IS IF THE CUSTOMER FOLLOWED THE CORRECT PROCEDURE FOR TESTING AS THEY DID NOT CONFIRM THE PROCEDURE WITH COMPANY REPRESENTATIVE. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HEALGEN HAS COMPLETED THE INVESTIGATION. AFTER REVIEWING THE RELEVANT MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT NUMBER 2203163EUA, NO IRREGULARITIES WERE FOUND. TESTS RETAINED FROM LOT NUMBER 2203163EUA 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.

    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 POSITIVE TEST RESULTS FOR COVID ON CLINITEST COVID19 SELF TEST WHEN COMPARED WITH RESULT FROM UNKNOWN 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
    1345592 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2203163EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female