BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 8031307 · Received November 1, 2018

    Report

    Report Number
    3013982035-2018-00030
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    September 30, 2018
    Report Date
    November 1, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W64250RB. NO ISSUES WITH TROPONINI 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 (97000HSEU) 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 K030286.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). THE CUSTOMER REPORTED THE FOLLOWING OCCURRING FOR A PATIENT. ON (B)(6) AT 8AM THE DOCTOR REQUESTED A POINT OF CARE TRIAGE CARDIAC PANEL BE PERFORMED ON A PATIENT. THE PATIENT SAMPLE WAS PROCESSED AND RESULTED A TRIAGE TNI OF <0.05NG/ML AT 8:33AM, REPORTED AS "NORMAL". AT 9:38AM A "CRITICAL" RESULT OF A QUANTITATIVE TROPONIN WITH A VALUE OF 0.2160NG/ML WAS RECEIVED. THE SAME SAMPLE WAS REPROCESSED ON BOTH PLATFORMS. ON TRIAGE AT 11:26AM THE SAMPLE YIELDED A TNI OF <0.05NG/ML. ON THE QUANTITATIVE TROPONIN AT 2:34PM A TNI OF 0.2010NG/ML WAS RECEIVED. TRIAGE CUT-OFF IS 0.4NG/ML. CUT-OFF FOR QUANTITATIVE TNI NOT REPORTED, ONLY STATED RESULTS WERE CRITICAL. PATIENT UNDERWENT CARDIAC CATHETERIZATION. DESPITE MULTIPLE ATTEMPTS, FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870818 TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC TRIPLE MARKER PANEL MMI QUIDEL CARDIOVASCULAR INC. 97000HSEU W64250RB

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR