BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 15394433 · Received September 9, 2022

    Report

    Report Number
    3002638284-2022-00010
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 8, 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

    Narratives

    Additional Manufacturer Narrative · 0

    UDI COULD NOT BE INCLUDED IN THIS REPORT SINCE CUSTOMER DID NOT PROVIDE LOT NUMBER. SIEMENS HAVE REQUESTED MORE INFORMATION FROM THE CUSTOMER TO PERFORM FURTHER INVESTIGATION. 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 NEGATIVE RESULT FOR COVID ON CLINITEST COVID19 SELF TEST. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806611 CLINITEST RAPID COVID-19 ANTIGEN TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown