BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS PANEL

    MDR report key: 9218961 · Received October 22, 2019

    Report

    Report Number
    3013982035-2019-00027
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    September 6, 2019
    Report Date
    September 23, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT T10431RN. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10431RN WERE REVIEWED AND FOUND THAT THE LOT MET FINAL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THIS CATALOG NUMBER (97000HSEU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97000HS, 510(K) NUMBER K030286.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT RESULTS BETWEEN TRIAGE AND SIEMENS DIMENSION EXL ANALYZER. TESTING ON TRIAGE PANEL RESULTED IN THE FOLLOWING: CKMB 1.8 NG/ML (ABOVE CUT-OFF OF 4.3 NG/ML), MYO 96.8 NG/ML (ABOVE CUT-OFF OF 107 NG/ML), TROP I <0.05 NG/ML (BELOW CUT-OFF OF 0.40 NG/ML). EXL ANALYZER: 0.215 NG/ML (ABOVE CUT-OFF OF 0.10 NG/ML). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013953 TRIAGE CARDIAC HS PANEL TRIAGE CARDIAC PANEL MMI QUIDEL CARDIOVASCULAR INC. 97000HSEU T10431RN

    Patients

    Seq Age Sex Outcome Treatment
    1