BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 7434896 · Received April 16, 2018

    Report

    Report Number
    3013982035-2018-00008
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Report Date
    April 16, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR, INC.
    Product Code
    DAP
    UDI-DI
    00899722002740
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W63556B. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W63556B WERE REVIEWED AND FOUND THAT THE LOT MET FINAL RELEASE SPECIFICATIONS. THE CUSTOMER COULD NOT PROVIDE PATIENT DIAGNOSIS FROM THE HOSPITAL SPECIALIZED IN CARDIOLOGY. THE ONLY INFORMATION AVAILABLE IS PATIENT IS IN GOOD HEALTH CONDITION. 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

    A PATIENT EXPERIENCED RESPIRATORY DISTRESS AND WAS TESTED FOR CARDIAC MARKERS USING THE TRIAGE SYSTEM. THE TRIAGE SYSTEM PRODUCED RESULTS OF TNI= <0.05 NG/ML AND BNP= 96 PG/ML. AS THE TRIAGE TNI RESULT WAS DETERMINED TO BE NORMAL BY THE CUSTOMER, THE PATIENT WAS TAKEN TO THE EMERGENCY UNIT OF A HOSPITAL INSTEAD OF A HOSPITAL WITH A CARDIOLOGY UNIT. THE PATIENT WAS TESTED IN THE EMERGENCY UNIT BY ANOTHER SERVICE AN HOUR LATER AND RECEIVED RESULTS OF TNI= 0.0792 NG/ML AND BNP= 387 PG/ML (NORMAL TNI CUTOFF FOR THIS INSTRUMENT= 0.034 NG/ML). AS THIS TNI RESULT WAS ABNORMAL, THE DECISION WAS MADE TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL SPECIALIZED IN CARDIOLOGY. THE PATIENT'S DIAGNOSIS PRIOR TO TRANSFER WAS HEART FAILURE AND CORONARY DISTRESS. AS OF MARCH 29, 2018, THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277355 TRIAGE PROFILER SOB PANEL KIT, TRIAGE, SOB DAP QUIDEL CARDIOVASCULAR, INC. 97300EU W63566B 00899722002740

    Patients

    Seq Age Sex Outcome Treatment
    1