BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE SOB PANEL

    MDR report key: 20096676 · Received August 29, 2024

    Report

    Report Number
    3013982035-2024-00015
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 28, 2024
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 SOB LOT T14761N WITH AN IN-HOUSE CALIBRATOR. 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

    TRIAGE SOB TNI DISCREPANT LOW VS LAB HSTNI PATIENT INFORMATION: MALE, 79 YEARS 11 MONTHS, SYMPTOMATIC PATIENT DIAGNOSIS: 3-VESSEL CHD, N-STEMI. TREATMENT: 3 STENTS (3RD STENT PLANNED). SAMPLE TYPE: EDTA WHOLE BLOOD (USED FOR BOTH TESTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523107 TRIAGE SOB PANEL TRIAGE SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T14761N

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male TRIAGE METERPRO PN: 55071, SN: (B)(6).