BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 7940995 · Received October 5, 2018

    Report

    Report Number
    3013982035-2018-00027
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Report Date
    October 5, 2018
    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

    PRODUCT DEVICE CODE (CONTINUED): DAP, DDR, AND JHX. INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W64218B. NO ISSUES WITH TROPONIN I 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

    THE EVENT OCCURRED IN (B)(6). A PATIENT WHO PRESENTED WITH FLU SYMPTOMS AND PAIN IN CHEST AFTER WALKING 500 METERS WAS TESTED WITH THE TRIAGE SOB PANEL AND RECEIVED A TROPONIN I RESULT OF 0.06NG/ML. THE PATIENT WAS TRANSFERRED TO A SPECIALIST AND TESTED 30 MINUTES LATER WITH THE LABORATORY RADIOMETER AND RECEIVED A TROPONIN T RESULT OF 0.055NG/L. PATIENT WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION AND HAD A STENT IMPLANTED. CUSTOMER STATED THERE WAS NO DELAY IN TREATMENT DUE TO THE TRIAGE RESULT. THE PATIENT IS NOW RELEASED FROM THE HOSPITAL AND IS STABLE. FACILITY TRIAGE TNI CUT-OFF: 0.4NG/ML. RADIOMETER TNT CUT-OFF: 0.02NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781601 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU W64218B

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR