BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 18133578 · Received November 14, 2023

    Report

    Report Number
    3009238284-2023-00013
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 24, 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 HAD BEEN SICK FOR OVER 18 DAYS. CUSTOMER TOOK A NON-SIEMENS TEST, RESULT OF WHICH CAME OUT NEGATIVE. SIMULTANEOUSLY, CUSTOMER TESTED WITH SIEMENS CLINITEST COVID-19 SELF TEST, 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. ALL TEST STRIPS PASSED LINE INTENSITY SPECIFICATION, ALL CONTROL LINES FORMED, AND NO WICKING ISSUES WERE OBSERVED. 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, (B)(6) 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 A NON-SIEMENS TEST THAT GAVE NEGATIVE RESULT. THE TEST RESULT FROM CLINITEST WAS QUESTIONED AS THE PATIENT HAD BEEN SICK FOR MORE THAN 18 DAYS. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927199 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC 2204628EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown