BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN TEST

    MDR report key: 15029220 · Received July 15, 2022

    Report

    Report Number
    3009238284-2022-00004
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    July 2, 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
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT CAME TO THE KNOWLEDGE OF SIEMENS HEALTHINEERS ON 07-11-2022 THROUGH FDA MEDWATCH PROGRAM EMAIL. CUSTOMER DID NOT CONTACT SIEMENS OR THE MANUFACTURER - HEALGEN. FURTHER INVESTIGATION WILL BE BASED ON LOT NUMBER PROVIDED, AS MANUFACTURER CANNOT CONTACT CUSTOMER. 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 THEMSELVES AND ANOTHER FAMILY MEMBER FOR COVID ON CLINITEST FOR LOT 220138EUA. THEY RECEIVED POSITIVE RESULTS ON NON-SIEMENS/HEALGEN RAPID TEST. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047723 CLINITEST RAPID COVID-19 ANTIGEN TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC LLC 2201380EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown