BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 15043464 · Received July 18, 2022

    Report

    Report Number
    3009238284-2022-00005
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    July 12, 2022
    Report Date
    September 13, 2022
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT CAME TO THE KNOWLEDGE OF SIEMENS HEALTHINEERS FROM THE MANUFACTURER HEALGEN. THE MANUFACTURER HAS REQUESTED MORE INFORMATION FROM THE CUSTOMER TO BE ABLE TO PERFORM FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. BASED ON THE LOT NUMBER PROVIDED BY THE CUSTOMER, NO IRREGULARITIES WERE FOUND AFTER REVIEWING THE RELEVANT MANUFACTURING DOCUMENTS. MANUFACTURER ALSO CONDUCTED TESTS ON SAMPLES RETAINED FROM THE LOT. THE SAMPLES MET THE QC STANDARD. BASED ON ABOVE INVESTIGATION, MANUFACTURER WAS UNABLE TO REPLICATE THE CUSTOMER'S COMPLIANT. 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 (B)(4) EUA. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883715 CLINITEST RAPID COVID-19 ANTIGEN TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2201376EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown