BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TNI PANEL

    MDR report key: 20252749 · Received September 18, 2024

    Report

    Report Number
    3013982035-2024-00021
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 17, 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

    THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINED DEVICES OF LOT T14915RN. NO ISSUES WITH RECOVERY WERE OBSERVED AND THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS FOR THE LOT 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 · 0

    CUSTOMER REPORTING THAT THERE HAVE BEEN 2 PATIENTS THAT HAVE GIVEN HIGHER THAN EXPECTED TNI RESULTS AND UPON REPEAT, A NORMAL EXPECTED RESULT IS OBTAINED. PATIENTS SYMPTOMS: CHEST PAIN PATIENTS DIAGNOSIS: DISCHARGED WITH FOLLOW UP TO CARDIOLOGIST THE NEXT DAY. NO TREATMENT PERFORMED. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526804 TRIAGE CARDIAC TNI PANEL TRIAGE CARDIAC TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T14915RN

    Patients

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