BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 11170114 · Received January 14, 2021

    Report

    Report Number
    3013982035-2021-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 15, 2020
    Report Date
    December 15, 2020
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN DEVICE LOT T11670N. RETAINS OF THE COMPLAINT LOT WERE TESTED WITH NORMAL "APPARENTLY HEALTHY" DONORS, ALL TNI RESULTS WERE NORMAL AND BELOW THE PRODUCTS ANALYTICAL SENSITIVITY OF 0.05NG/ML. NO ISSUES WITH TNI RECOVERY WERE OBSERVED, THE LOT PERFORMED PROPERLY MANUFACTURING BATCH RECORDS FOR LOT T11670N 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

    CUSTOMER REPORTED DISCREPANT TROPONIN RESULTS ON A PATIENT. PATIENT WAS TESTED 5 TIMES ON TRIAGE; YIELDING ALL ELEVATED RESULTS FOR TROPONINI 1.23NG/ML, 0.60NG/ML, 1.03NG/ML, 0.72NG/ML AND 0.60NG/ML (CUT-OFF 0.40NG/ML). PATIENT SAMPLE WAS SENT TO THE LAB WHERE TROPONINT MEASURED NORMAL AT 4NG/L (CUT-OFF 50NG/L). ULTRASONIC AND ECG WERE NEGATIVE AND NO RENAL INSUFFICIENCY. CUSTOMER STATED PATIENT IS ABSOLUTELY HEALTHY AND WAS SENT HOME AFTER RECEIVING LAB RESULT. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71595 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T11670N

    Patients

    Seq Age Sex Outcome Treatment
    1