BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 15229934 · Received August 15, 2022

    Report

    Report Number
    3009238284-2022-00008
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 15, 2022
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PCR TEST WAS DONE AT DOCTOR'S CLINIC, RESULT OF WHICH CAME OUT POSITIVE LATER. THEREAFTER, THE CUSTOMER TOOK THE COVID SELF TEST AT HOME RESULT OF WHICH WAS NEGATIVE. DUE TO POSITIVE TEST, PAXLOVID WHICH WAS RECOMMENDED BY DOCTOR. MORE INFORMATION FROM THE CUSTOMER HAS BEEN REQUESTED TO BE ABLE 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 FOR LOT: 2202134EUA THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287977 CLINITEST RAPID COVID-19 ANTIGEN TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2202134EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown