BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TNI PANEL

    MDR report key: 20252503 · Received September 18, 2024

    Report

    Report Number
    3013982035-2024-00019
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 18, 2024
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS ISSUE IS ONGOING.

    Additional Manufacturer Narrative · 0

    UNABLE TO DETERMINE THE ROOT CAUSE OF THE DISCREPANT HIGH TNI OBSERVATION. IN-HOUSE TESTING ILLUSTRATED THAT THE PRODUCT IS PERFORMING AS EXPECTED RELATIVE TO THE COMPLAINT AND THE DATA HAS BEEN DETERMINED TO BE ACCEPTABLE ACCORDING TO THE RISK STATEMENT. ALTHOUGH AN EXACT ROOT CAUSE HAS NOT BEEN DETERMINED, THE ISSUE WAS NOT REPEATED WITH ADDITIONAL TESTING AND APPEARS TO BE AN ISOLATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER PREVIOUSLY REPORTED THAT THERE HAVE BEEN 2 PATIENTS WHO RECEIVED HIGHER THAN EXPECTED TNI RESULTS AND UPON REPEAT, A NORMAL EXPECTED RESULT WAS OBTAINED. A FIELD APPLICATION SPECIALIST VISITED THE SITE AND REPORTED A 3RD PATIENT WHO RECEIVED HIGHER THAN EXPECTED TNI RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531923 TRIAGE CARDIAC TNI PANEL TRIAGE CARDIAC TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T14913RN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRIAGE METERPRO PN:55070 SN:(B)(6).