BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 7961878 · Received October 12, 2018

    Report

    Report Number
    3013982035-2018-00028
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 12, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 W64051RB. NO ISSUES WITH TROPONIN 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 ONLY INFORMATION PROVIDED FROM THE CUSTOMER: A PATIENT SAMPLE WAS NEGATIVE ON TRIAGE WITH A TNI RESULT OF <0.05NG/ML ON (B)(6). A SECOND SAMPLE FROM THE SAME PATIENT WAS POSITIVE ON ABBOTT WITH A TNI RESULT OF 564PG/ML. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS PROVIDED. TRIAGE CUT-OFF: >0.05NG/ML. CUT-OFF FOR ABBOTT WAS NOT PROVIDED; CUSTOMER ONLY STATED THE RESULT OF 564PG/ML WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801381 TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC TRIPLE MARKER PANEL MMI QUIDEL CARDIOVASCULAR INC. 97000HSEU W64051RB

    Patients

    Seq Age Sex Outcome Treatment
    1