BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 1213195 · Received October 22, 2008

    Report

    Report Number
    2027969-2008-00030
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. DUPLICATED CUSTOMER RESULTS WITH RETURNED SPECIMEN. ADDITION OF HAMA BLOCKER REDUCED BECKMAN ACCESS RESULT CA. 30%, BUT SIGNIFICANCE AGAINST OCCURRENCE INDETERMINATE. LOT REVIEW INDICATED NO FAILURE AGAINST RELEASE SPECIFICATIONS. DEFICIENCY NOT ESTABLISHED. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 1

    TRIAGE CARDIAC PANEL TROPONIN (TNI) RESULTS <0.05 NG/ML ON 3 DRAWS, ACCESS TNI RESULTS OF 9.92 NG/ML AND 12 NG/ML ON 2 OR 3 DRAWS; CUSTOMER SUSPECTS FALSE ELEVATION ON ACCESS. HOWEVER, POSSIBLE FALSE NEGATIVE RESULTS WITH TRIAGE CARDIAC PANEL MAY LEAD TO MISSED DIAGNOSIS FOR MI. THE PT WAS SEEN IN THE ED, AND PT WAS ADMITTED TO HOSPITAL BUT NO OTHER CLINICAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97000HS W43568

    Patients

    Seq Age Sex Outcome Treatment
    1