BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 1569422 · Received December 16, 2009

    Report

    Report Number
    2027969-2009-01165
    Event Type
    Injury
    Date Received
    December 16, 2009
    Date of Event
    November 19, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL 25 TEST VS BECKMAN DXI. FEMALE WITH CHEST PAIN AND A STRONG SUSPECT OF SUDDEN CARDIAC ARREST (SCA) WAS ADMITTED TO THE CARDIOLOGY WARD. SHE HAD DONE A PERCUTANEOUS CORONARY INTERVENTION (PTCI): CORONARY ARTERY BYPASS GRAFT. HER FINAL DIAGNOSIS WAS SCA, NSTEMI. (NON ST ELEVATION MYOCARDIO INFARCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97000HS W45247

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R