BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 15441911 · Received September 16, 2022

    Report

    Report Number
    3009238284-2022-00011
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 3, 2022
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    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

    SIEMENS SHOWED DUE DILIGENCE IN ATTEMPTING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER HOWEVER, THE CUSTOMER HAS NOT RESPONDED AFTER MULTIPLE ATTEMPTS. WITHOUT THE LOT INFORMATION, FURTHER INVESTIGATION IS NOT POSSIBLE. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    UDI COULD NOT BE INCLUDED IN THIS REPORT SINCE CUSTOMER DID NOT PROVIDE LOT NUMBER. NO INVESTIGATION POSSIBLE WITHOUT LOT NUMBER. THE MANUFACTURER REQUESTED MORE INFORMATION FROM THE CUSTOMER TO PERFORM FURTHER INVESTIGATION, HOWEVER NO RESPONSE WAS RECEIVED FROM THE CUSTOMER EVEN AFTER MULTIPLE ATTEMPTS. TWO CONSECUTIVE TESTS HAD DIFFERENT RESULTS AND IN ABSENCE OF A CONFIRMATORY TEST LIKE PCR. CLARITY MISSING ON FALSE NEGATIVE OR FALSE POSITIVE. ALSO NOT KNOWN IS IF THE CUSTOMER FOLLOWED THE CORRECT PROCEDURE FOR TESTING. 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 NEGATIVE AND POSITIVE RESULT FOR COVID ON TWO CONSECUTIVE CLINITEST COVID19 SELF TESTS FROM THE SAME KIT. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651286 CLINITEST RAPID COVID-19 ANTIGEN TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown