BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIO PROFILER KIT

    MDR report key: 1692017 · Received May 13, 2010

    Report

    Report Number
    2027969-2010-00580
    Event Type
    Injury
    Date Received
    May 13, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 13, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT TESTED RETURNED PT SAMPLE IN-HOUSE AND OBSERVED THE FOLLOWING ANALYTE RESULTS: TRIAGE (NG/ML) CKMB 3.6, TNI 10.7, MYO 165, BNP 1325 (PG/ML). ACCESS (NG/ML) TNI 14.38. TNI RESULTS WERE CONSISTENT BETWEEN THE TWO METHODS. TNI RESULTS ON THIS SAMPLE ((B) (6) 2010 DRAW DATE) WERE NOT COMPARABLE WITH RESULTS FROM CLIENT'S (B) (6) 2010, SAMPLE DRAW. ADDITIONAL RETENTION TESTING ON THE DEVICE LOT USING POSITIVE CONTROL SAMPLE YIELDED RESULTS WITHIN THE VALUE ASSIGNMENT 2SD RANGE. NO PRODUCT DEFICIENCY WAS ESTABLISHED; NO CORRECTIVE ACTON REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE TROPONIN I (TNI) RESULT ON TRIAGE CARDIO PROFILER KIT VS BCI LAB ANALYZER. PT PRESENTED WITH CHEST PAIN RADIATING TO ARM. TNI RESULTS ON TRIAGE GAVE A NEGATIVE RESULT. SAMPLE WAS RUN IN LAB ON BCI AND GAVE POSITIVE RESULT. REFERENCE RANGE ON BOTH TRIAGE AND BCI IS 0.07 NG/ML. PT WAS TRANSFERRED FOR CARDIAC CATH LATER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PROFILER KIT CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97100CP W46567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention