BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 1911473 · Received November 18, 2010

    Report

    Report Number
    2027969-2010-01996
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN PRODUCT SUPPORT RECEIVED PT SAMPLE THE ICE AND THE SAMPLE WERE NO LONGER FROZEN. POSSIBLE DEGRADATION COULD HAVE OCCURRED. PRODUCT SUPPORT TESTED RETURNED SAMPLE ON PROFILER LOT # W46655 (LOT # W46654 WAS NOT AVAILABLE FOR TESTING), AND ACCESS2. TWO REPS ON ACCESS 2 (BOTH REPS TNI <0.01 NG/ML) AND 2 REPS ON TRIAGE W46655 (BOTH REPS TNI <0.05 NG/ML). CUSTOMER FALSE POSITIVE RESULT WAS NOT REPRODUCED. CUSTOMER STATED THEY LEFT THE SAMPLE IN THE REFRIGERATOR OVERNIGHT AFTER INITIAL TEST AND BEFORE RETEST. AND SAMPLE MIGHT NOT HAVE COME TO ROOM TEMPERATURE BEFORE RETEST. THE PACKAGE INSERT STATES "TEST BLOOD SPECIMENS ON THE TEST DEVICE IMMEDIATELY OR WITHIN 4 HOURS OF COLLECTION. IF TESTING CANNOT BE COMPLETED WITHIN 4 HOURS, THE PLASMA SHOULD BE SEPARATED AND STORED AT -20 C UNTIL IT CAN BE TESTED." SAMPLE COULD HAVE DEGRADED BETWEEN 1ST TEST AND RETEST THE NEXT DAY. NO PRODUCT DEFICIENCY WAS ESTABLISHED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE POSITIVE TROPONIN (TNI) RESULT USING THE TRIAGE CARDIAC PROFILER KIT. CUSTOMER IS NOT AWARE OF ANY INVASIVE PROCEDURE PERFORMED ON THE PT BASED ON THE TNI RESULTS. DIAGNOSIS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC 97100CP W46654

    Patients

    Seq Age Sex Outcome Treatment
    1