BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 1213196 · Received October 22, 2008

    Report

    Report Number
    2027969-2008-00031
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT (PS) TESTED THE RETURNED PLASMA SAMPLE FOR TNI RECOVERY ON BOTH TRIAGE CARDIAC PANEL AND BECKMAN ACCESS PLATFORMS. PS ALSO TREATED THE SAMPLE FOR HAMA ANTIBODY INTERFERENCE. CUSTOMER COMPLAINT CONFIRMED LOW RECOVERY OF TNI IN RETURNED SPECIMEN ON TRIAGE AGAINST BECKMAN ACCESS. DEVICE CONTROL RECOVERED WITHIN EXPECTED RANGE. LOT REVIEW INDICATED NO FAILURE AGAINST RELEASE SPECIFICATIONS. DEFICIENCY FINDINGS INDETERMINATE. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 1

    POTENTIAL FALSE NEGATIVE RESULTS FOR TROPONIN (TNI) ON TRIAGE CARDIAC , BECKMAN ACCESS TNI=0.13 NG/ML. POSSIBLE FALSE NEGATIVE RESULTS WITH TRIAGE CARDIAC PANEL MAY LEAD TO MISSED DIAGNOSIS FOR MI. PT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97000HS W42657B

    Patients

    Seq Age Sex Outcome Treatment
    1