BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST

    MDR report key: 20638454 · Received November 8, 2024

    Report

    Report Number
    3012234563-2024-00002
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 7, 2024
    Manufacturer
    CORDX, INC.
    Product Code
    QMN
    UDI-DI
    00850042559635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EUA NO: (B)(4). ON OCTOBER 10TH, A PROVIDER FROM (B)(6) REPORTED MULTIPLE FALSE POSITIVE RESULTS WHILE USING OUR 3-IN-1 POC TESTS. APPROXIMATELY HALF OF A 25T BOX FROM BATCH NUMBER US2429810 WAS USED. INVESTIGATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY SHOWED NO ADVERSE TRENDS RELATED TO THIS ISSUE. THE DEVICE HISTORY RECORD (DHR) FOR LOT US2429810 WAS REVIEWED, AND NO DISCREPANCIES WERE FOUND. RETENTION SAMPLES WERE TESTED, AND ALL RESULTS MET QC RELEASE CRITERIA. THE FALSE POSITIVE RATE WAS WITHIN THE EXPECTED RANGE, AND THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR THE TREND CLOSELY.

    Description of Event or Problem · 0

    ON OCTOBER 10TH, A PROVIDER FROM (B)(6) RAISED A COMPLAINT REGARDING MULTIPLE FALSE POSITIVE RESULTS OBSERVED WHILE USING CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST POC TESTS. APPROXIMATELY HALF OF A BOX OF 25T TESTS FROM BATCH NUMBER US2429810 WAS USED. MULTIPLE TESTS SHOWED POSITIVE RESULTS FOR BOTH FLU A AND FLU B, EVEN IN ASYMPTOMATIC PATIENTS. SOME TESTS SHOWED SIMULTANEOUS POSITIVE RESULTS FOR FLU A/B AND COVID-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815049 CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST QMN CORDX, INC. ACT21002-25 US2429810 00850042559635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other