BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 8742135 · Received June 27, 2019

    Report

    Report Number
    3013982035-2019-00012
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Report Date
    June 27, 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

    TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER. INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT T10134N. NO ISSUES WITH TROPONIN I RECOVERY WERE OBSERVED; LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, 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 (97000HS), 510(K) NUMBER K973126.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A TRIAGE TNI RESULT OF 0.08 NG/ML COMPARED TO HOSPITAL LAB TNT OF 33 NG/L. CLINICAL DIAGNOSIS IS STEMI. PATIENT UNDERWENT A HEART CATHETER: TRIPLE VESSEL DISEASE/ CORONARY VASCULAR DISEASE (RIVA,RCX/RIVP), 4 STENTS WERE IMPLEMENTED.  CUSTOMER REPORTED A D-DIMER RESULT OF 1380 NG/ML.  LAB IN HOSPITAL CUTOFF FOR TNT= <14NG/L. NO FURTHER PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535339 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T10134N

    Patients

    Seq Age Sex Outcome Treatment
    1