BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 1172689 · Received September 20, 2008

    Report

    Report Number
    2027969-2008-00013
    Event Type
    Malfunction
    Date Received
    September 20, 2008
    Date of Event
    July 31, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINS TESTED WITH RETURNED PT SPECIMENS. PRODUCT SUPPORT (PS) OBSERVED HIGH TNI AND CK-MB RESULTS ON TRIAGE AND LOW RESULTS ON ACCESS. PS ALSO OBSERVED THAT THE ADDITION OF HAMA INTERFERENCE BLOCKERS LOWERED TNI AND CK-MB SIGNAL 7-FOLD AND 3-FOLD. USING A SEMI-QUANTITATIVE HAMA ACTIVITY ELISA, PS OBSERVED FOR ONE SERUM SAMPLE THAT THE AMOUNT OF HUMAN ANTI-MOUSE IGG WAS CLOSE TO OR ABOVE THE HIGH END OF THE RANGE FOR NORMAL HEALTHY MALES (BASED ON PRODUCT INSERT). LOT REVIEW INDICATED NO FAILURE. RISK ASSESSMENT AND CAPA EVAL PENDING.

    Description of Event or Problem · 1

    PT HAD POSITIVE CKMB AND TROPONIN I (TNI) RESULTS. WAS TREATED FOR MI WITH HEPARIN INFUSION BEFORE LAB RESULTS RETURNED WITH NORMAL LEVELS. CATHETERIZATION WAS ORDERED BUT CANCELLED DUE TO RESULTS FROM THE LAB. SAMPLE TESTED 2008, 4:58P RESULTS WERE CKMB-29.1, MYO=138, TNI=0.72. REDRAW AT 5:41PM WAS CKMB=23.1, MYO=149, TNI=0.37. 2ND REDRAW AT 6:48PM WAS CKMB=20.1, MYO=113, TNI=0.38. LAB RESULTS ON HEPARIN SAMPLE (UNK DRAW TIME) - CKMB= 3.2, TNI=<0.01. UNK METHOD. PT WAS ADMITTED FOR MONITORING POSSIBLE MI BUT HAS NOT REPORTED ANY ADVERSE EFFECTS DUE TO HEPARIN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97000HS W43180

    Patients

    Seq Age Sex Outcome Treatment
    1