BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SHORTNESS OF BREATH PANEL

    MDR report key: 1203755 · Received October 10, 2008

    Report

    Report Number
    2027969-2008-00025
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT (PS) TESTED RETURNED AND RETAINED DEVICES. PS DID NOT OBSERVE HIGH OUTLIERS DURING CALIBRATOR & WHOLE BLOOD TESTING. PS DID NOT CONFIRM THE CLIENT'S OBSERVATIONS WITH IN-HOUSE TESTING. CUSTOMER COMPLAINT COULD NOT BE DIRECTLY CONFIRMED FOR LACK OF SPECIMEN. TESTING WITH RETAINED PRODUCT INDICATED NO OUTLIER RESULTS TO WHICH THE FALSE POSITIVE TNI RESULTS COULD BE ATTRIBUTED. BATCH RECORD REVIEW INDICATED SINGLE POINT OUTLIERS ON EACH OF 2 DAYS WHEN NON-DISEASED PT WHOLE BLOOD WAS EXAMINED. DEFICIENCY ESTABLISHED. RELEASE SPECIFICATION EVALUATION PENDING.

    Description of Event or Problem · 1

    FALSE NEGATIVE TROPONIN I (TNI) RESULTS AT <0.05 NG/ML AND 2ND OF 3 SERIAL DRAWS FOR ONE PT; REPEATING THE SAMPLE IN QUESTION USING PLASMA INSTEAD OF WHOLE BLOOD GAVE RESULTS OF 0.07 NG/ML AND 0.08 NG/ML. NO FURTHER INFO PROVIDED ON PT DIAGNOSIS OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SHORTNESS OF BREATH PANEL CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97300 W43020

    Patients

    Seq Age Sex Outcome Treatment
    1