BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 8453631 · Received March 26, 2019

    Report

    Report Number
    3013982035-2019-00005
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 26, 2019
    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: CUSTOMER STATED THE TRIAGE RESULTS HAD NO IMPACT ON PATIENT TREATMENT. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W64973N. NO ISSUES WITH RECOVERY WERE OBSERVED; LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, LOT MET 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 A FALSE NEGATIVE TNI OBTAINED ON THE TRIAGE SOB PRODUCT. PATIENT COMPLAINED ABOUT BREAST PAIN STARTING ON SATURDAY. ON MONDAY, (B)(6) 2019, THE PATIENT WENT TO SEE HIS PHYSICIAN, AND WAS TESTED USING THE TRIAGE SOB PANEL AT 9:47AM. RESULTS WERE: TNI = 0.23, CKMB=7.1, MYO=128, BNP=372, D-DIMER=222. CUSTOMER STATED THE CKMB, MYO AND BNP RESULTS WERE ABNORMAL. AT 9:50 AN ECG WAS PERFORMED IN THE PHYSICIANS OFFICE. CUSTOMER STATED ECG SHOWED CHANGES SO THE PATIENT WAS SENT TO THE HOSPITAL. AT 12:25PM A HIGH SENSITIVITY TROP. IN HOSPITAL LAB WAS TESTED, RESULT = 1137PG/ML. "RIVA STENOSIS CONFIRMED IN HOSPITAL LAD: LEFT ANTERIOR DESCENDING. PATIENT UNDERWENT CORONARY ANGIOGRAPHY AND STENT IMPLANTATION. PATIENT DIAGNOSED IN HOSPITAL WITH MYOCARDIAL INFARCTION. FACILITY REF. RANGES: TRIAGE TNI: 0.40NG/ML LAB: 34.3 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244246 TRIAGE PROFILER SOB PANEL TRIAGE SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU W64973N

    Patients

    Seq Age Sex Outcome Treatment
    1