BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 14250387 · Received April 29, 2022

    Report

    Report Number
    3008573045-2022-00132
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    UDI-DI
    00208563205894
    PMA / PMN Number
    EUA210470
    Removal / Correction Number
    MW5108515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRESPONDING TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT:212CO21228), THE NEGATIVE COINCIDENCE RATE TEST WAS CARRIED OUT, AND THE TEST RESULTS SHOWED THAT THE NEGATIVE COINCIDENCE RATE WAS 100%.NO FALSE POSITIVES FOUND REVIEW THE PERFORMANCE INSPECTION DATA OF 212CO21228 BATCHES OF PRODUCTS, AND THE INSPECTION RESULTS ARE QUALIFIED.

    Description of Event or Problem · 0

    FALSE POSITIVE TEST RESULT STAFF MEMBER WAS TESTED USING IHEALTH COVID-19 ANTIGEN RAPID TEST. TEST RESULT WAS POSITIVE. STAFF HAD NO SYMPTOMS OR EXPOSURE. STAFF WAS THEN TESTED USING BINAXNOW COVID-19 ANTIGEN RAPID TEST AND CARESTART COVID-19 ANTIGEN RAPID TEST. BOTH TESTS WERE NEGATIVE. COVID-19 PCR TEST WAS THEN PREFORMED. TEST RESULTS WHERE NEGATIVE CONFIRMING A FALSE POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98782 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 212CO21228 00208563205894

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown