BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC HS TNI PANEL

    MDR report key: 24842448 · Received April 10, 2026

    Report

    Report Number
    3013982035-2026-00017
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 9, 2026
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    UDI-DI
    30014613337935
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF DISCREPANT RESULTS WITH TNI WAS NOT REPLICATED WITH IN-HOUSE RETAIN TESTING OF TRIAGE CARDIAC LOT T16279RN WITH NATIVE WHOLE BLOOD. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. 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

    EVENT OCCURRED IN THE UNITED STATES OF AMERICA. CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS WITH MULTIPLE PATIENTS USING TRIAGE CARDIAC LOT T16279RN. PATIENT INFORMATION: PATIENT 4: (B)(6) 2026 M 53 Y/O SX: PMHX OF HTN AND LEFT VENTRICULAR HYPERTROPHY INITIALLY PRESENTS FOR TROUBLE SLEEPING OVER THE PAST WEEK. HE WAS SENT BY HIS THERAPIST TO POSSIBLY GET PRESCRIBED MEDICINE TO HELP HIM SLEEP. HE'S HAD ASSOCIATED CHEST TIGHTNESS AND SHORTNESS BREATH X3-4 DAYS; DISCHARGE DIAGNOSIS: ANXIETY; TREATMENT BASED ON HEART SCORE/TROPONIN RESULTS. MEDICAL INTERVENTIONS/PROCEDURES: EKGS HEART SCORE NO DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904233 TRIAGE CARDIAC HS TNI PANEL TRIAGE CARDIAC HS TNI PANEL MMI QUIDEL CARDIOVASCULAR INC. 97021HS T16279RN 30014613337935

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male PN: 55070 SN: (B)(6).