BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 7103032 · Received December 10, 2017

    Report

    Report Number
    2024674-2017-00006
    Event Type
    Malfunction
    Date Received
    December 10, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 8, 2017
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62906RB. NO ISSUES WITH ANALYE RECOVERY WERE OBSERVED AND THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER STATED A PATIENT WAS TESTED AT A DIFFERENT INSTITUTE (HOSPITAL (B)(6)) ON PATH FAST AND YIELDED AN ABNORMAL TNI RESULT OF 17NG/ML. WHEN THE PATIENT WAS TESTED AT THE CUSTOMERS CLINIC THE PATIENT YIELDED A NORMAL TNI ON TRIAGE CARDIAC PANEL OF <0.05NG/ML. CUSTOMER ASSURES THE TIME DIFFERENCE BETWEEN THE TWO TESTS WAS LESS THAN 24 HOURS. THE RESULT OBTAINED FROM THE TRIAGE DID NOT INFLUENCE OR ALTER PATIENT CARE, THE PHYSICIAN ADMINISTERED TREATMENT BASED ON ELECTROCARDIOGRAM RESULTS, THE SYMPTOMS AND THE RESULT OF THE PATH FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882360 TRIAGE CARDIAC TRIPLE MARKER PANEL IMMUNOASSAY METHOD, TROPONIN SUBUNIT, PRODUCT CODE: MMI MMI QUIDEL CARDIOVASCULAR INC. 97000HSEU W62906RB

    Patients

    Seq Age Sex Outcome Treatment
    1