BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, TRIAGE, CARDIAC TNI/CKMB

    MDR report key: 7051016 · Received November 21, 2017

    Report

    Report Number
    2024674-2017-00001
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Report Date
    October 23, 2017
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W63248RB. NO ISSUES WITH ANALYTE RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET ALL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE RESULTS ON THE TRIAGE CARDIAC PANEL ON A PATIENT THAT LATER TESTED POSITIVE FOR MI IN MICU. LAB SUPERVISOR STATED THE CARDIAC RESULTS DID BEHAVE AS EXPECTED BASED ON THE TIMING OF THE DRAWS; HOWEVER, THE ER DOCTOR IS STILL SKEPTICAL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828429 KIT, TRIAGE, CARDIAC TNI/CKMB IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI QUIDEL CARDIOVASCULAR INC. 97022HS W63248RB

    Patients

    Seq Age Sex Outcome Treatment
    1