BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 18133575 · Received November 14, 2023

    Report

    Report Number
    3009238284-2023-00014
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 30, 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

    MORE INFORMATION REQUESTED FROM THE CUSTOMER TO PERFORM FURTHER INVESTIGATION. CUSTOMER TOOK AN UNKNOWN TEST AT DOCTOR'S OFFICE 2 WEEKS AGO, RESULT OF WHICH CAME OUT POSITIVE. RECENTLY ON (B)(6) 2023 DURING VISIT TO DOCTOR'S OFFICE, TEST PERFORMED PRODUCED NEGATIVE RESULT. CUSTOMER RETESTED WITH SIEMENS CLINITEST COVID-19 SELF TEST ON (B)(6) 2023 RESULT OF WHICH CAME OUT POSITIVE. 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 2203469EUA, NO IRREGULARITIES OR DEVIATIONS WERE OBSERVED. TESTS RETAINED FROM LOT NUMBER 2203469EUA 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. 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 POSITIVE TEST RESULT FOR COVID ON CLINITEST COVID19 SELF TEST WHEN COMPARED WITH RESULT FROM AN UNKNOWN TEST AT DOCTOR'S OFFICE. THE CUSTOMER HAD CONTRACTED COVID-19 2 WEEKS AGO WHICH WAS CONFIRMED AT DOCTORS OFFICE. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927196 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC 2203469EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female