BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE SOB PANEL

    MDR report key: 18387258 · Received December 22, 2023

    Report

    Report Number
    3013982035-2023-00037
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 22, 2023
    Report Date
    December 21, 2023
    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 WAS NOT REPLICATED WITH IN-HOUSE RETAIN TESTING OF TRIAGE SOB T14408N WITH AN IN-HOUSE CALIBRATOR. NO ISSUES WITH TNI RECOVERY WERE OBSERVED, THE LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD FOR TRIAGE SOB LOT T14408N. THE LOT MET ALL FINAL RELEASE SPECIFICATIONS. NO ISSUES WITH TNI RECOVERY WERE OBSERVED.BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY OF THIS PRODUCT FOR THE REPORTED FAILURE MODE; NO ISSUES WERE IDENTIFIED. THIS TREND WILL BE CONTINUOUSLY MONITORED THROUGH INCOMING COMPLAINTS.

    Description of Event or Problem · 0

    EVENT OCCURRED IN (B)(6). CONFLICTING RESULTS ON 1 PATIENT. TRIAGE SOB VS LAB TNT. SYMPTOMS: NO SYMPTOMS. DIAGNOSIS: CARDIO DECOMPENSATION, NSTEMI WITH 3-GEF-KHK. PATIENT TREATED BASED ON LAB TNT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570039 TRIAGE SOB PANEL TRIAGE SOB PANEL MMI QUIDEL CARDIOVASCULAR INC. 97300EU T14408N

    Patients

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