BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19631036 · Received June 28, 2024

    Report

    Report Number
    3012234563-2024-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Report Date
    June 26, 2024
    Manufacturer
    CORDX, INC.
    Product Code
    QMN
    UDI-DI
    00850042559635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EUA NO: (B)(4) DISTRIBUTOR FEEDBACK ON (B)(6) 2024, USER RECEIVED FLU A AND FLU B POSITIVE RESULT HOWEVER, REPEAT TEST USING ANOTHER MANUFACTURER TEST KIT WAS NEGATIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.. INVESTIGATION SUMMARY: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS FOR THE REPORTED ISSUE. LOT NUMBER US2415801 DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. RETENTION SAMPLES WERE TESTED, ALL TESTING MEET QC RELEASE CRITERIA. UNABLE TO DETERMINE THE ROOTCAUSE. WILL CONTINUE TO MONITOR THE TREND.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CORDX INC. RECEIVED FEEDBACK FROM BDSC (DISTRIBUTOR), STATING THAT THERE WERE FALSE POSITIVE RESULTS REPORTED (FLU A AND FLU B) WITH CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST BY END USERS. END USERS PERFORMED RE-TEST USING ANOTHER MANUFACTURER TEST KITS AND THE RESULTS WERE NEGATIVE. THE ACTUAL DATE OF THE TESTING WAS NOT PROVIDED. NO IMAGES OR RAW DATA FOR THE TESTING RESULTS COULD BE SHARED WITH CORDX TO ASSESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191953 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 US2415801 00850042559635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other