BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 10945491 · Received December 4, 2020

    Report

    Report Number
    3013982035-2020-00035
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    September 10, 2020
    Report Date
    November 16, 2020
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN DEVICE LOT T11323N. NO ISSUES WITH TNI RECOVERY WERE OBSERVED, THE LOT PERFORMED PROPERLY MANUFACTURING BATCH RECORDS FOR LOT T11323N 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, THE EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97300, 510(K) NUMBER K080269.

    Description of Event or Problem · 1

    PATIENT WITH CHRONIC CORONARY SYNDROME AND KNOWN CHRONIC ELEVATED TROPONIN PLASMA LEVELS PRESENTED TO THE CARDIOLOGISTS OFFICE WITH SEVERE ANGINA PECTORIS DISCOMFORTS. CUSTOMER ALLEGES THE PATIENT WAS TESTED ON THE TRIAGE METER ON (B)(6) 2020 BUT THE METER PRINT-OUT SHOWS TESTING DATE OF (B)(6) 2020. TRIAGE METER PRODUCED A TROPONINI (TNI) RESULT OF 0.20NG/ML. CUSTOMER USES A TRIAGE TNI CUT-OFF OF 0.40NG/ML. FROM THE CUSTOMER PROVIDED DOCUMENTS, THE PATIENT WAS TESTED ON A LAB INSTRUMENT ON (B)(6) 2020 AND PRODUCED A TROPONINT (TROPT) RESULT OF 169.0NG/L. CUSTOMER USES A TROPT CUT-OFF OF 14.0NG/L. ON (B)(6) 2020 PATIENT WAS TESTED AGAIN; TROPT RESULT OF 198.0NG/L, TRIAGE TNI RESULT OF 0.08NG/ML AND ALTERNATE TROPONINI HS (NOT TRIAGE) OF 0.254NG/ML (CUT-OFF 0.081NG/ML). THE CLINICAL DIAGNOSIS OF THE PATIENT WAS: CORONARY HEART DISEASE OVER THE COURSE OF YEARS, STABLE. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON NOVEMBER 16, 2020 STATING THAT "CORONARY ANGIOGRAPHY WAS DONE ON HIM SOME DAYS LATER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415127 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T11323N

    Patients

    Seq Age Sex Outcome Treatment
    1