BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 9260751 · Received October 31, 2019

    Report

    Report Number
    3013982035-2019-00029
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Report Date
    October 1, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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 T10226B. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10226B 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 (97300EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97300, 510(K) NUMBER K080269. .

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT TROPONIN RESULTS BETWEEN TRIAGE AND MINIVIDAS. 63 YEAR-OLD MALE TESTED ON TRIAGE AND PRODUCED A TNI OF 0.27NG/ML. MINIVIDAS RESULTED = 1114.8NG/L. SAMPLE ALSO TESTED ON TRIAGE CARDIO PRODUCT AND YIELDED A TNI OF 0.39NG/ML. MINIVIDAS CUT-OFF: MALE IS >25NG/L. TRIAGE SOB TROPONIN CUT-OFF: 0.40 NG/ML. BASED ON THE MINIVIDAS RESULT AND CLINICAL SYMPTOMS THE PATIENT HAD A PERIPHERAL ARTERY ANGIOPLASTY AND A STENT PLACEMENT. CUSTOMER STATED THE PATIENT WAS UNAFFECTED BY THE TRIAGE RESULTS BECAUSE TRIAGE WAS STILL IN EVALUATION PHASE. CUSTOMER USED MINIVIDAS FOR THEIR CLINICAL DECISION. NOTE THE TRIAGE CARDIO PANEL IS NOT DISTRIBUTED IN THE US NOR IS THERE A PRODUCT SAME OR SIMILAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057916 TRIAGE PROFILER SOB PANEL TRIAGE SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T10226B

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR