BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PROFILER KIT

    MDR report key: 2230934 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01601
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT CONDUCTED TESTING OF PROFILER W48412 WITH 2 NORMAL (APPARENTLY HEALTHY) WHOLE BLOOD DONORS, CALIBRATOR Z (NEGATIVE CONTROL), AND CALIBRATOR H (POSITIVE CONTROL). OBSERVATIONS WILL BE FOR TNI RECOVERY. OBSERVATIONS FOR TNI RECOVERY FOLLOW: NO HIGH BIAS OR FALSE POSITIVE RESULTS FOR TNI RECOVERY WERE OBSERVED WITH ANY SAMPLE. NO ERROR CODES WERE OBSERVED. ALL DATA POINTS WITH CAL Z AND THE NORMAL WHOLE BLOOD DONORS WERE BELOW THE MFG CUT OFF OF 0.05 NG/ML. ALL DATA POINTS WITH CAL H WERE WITH IN THE MFG 2SD RANGE, WITH A % RECOVERY OF 102% (WITH IN THE MFG FINAL RELEASE SPECS). NO HIGH BIAS WAS OBSERVED WITH THE POSITIVE CONTROL SAMPLE AND NO FALSE POSITIVE RESULT WAS OBSERVED WITH THE NEGATIVE CONTROL SAMPLE OR THE NORMAL WHOLE BLOOD DONORS. NO SAMPLE WAS RETURNED FOR TESTING; PRODUCT SUPPORT WAS UNABLE TO VERIFY THE CUSTOMER'S RESULT. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTOR THAT MAY HAVE AFFECTED ANALYTE RECOVERY. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE POSITIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIO PROFILER VS ORTHO VITROS ECI INSTRUMENT. CUSTOMER WAS LOOKING THROUGH TRIAGE METER RESULTS AND FOUND TWO PTS WHO HAD RESULTS DIFFERING FROM THOSE OF THEIR ORTHO VITROS ECI INSTRUMENT AND RE-RUNS USING THE SAME TRIAGE METER. EACH PT HAD 3 DRAWS DONE. CALLER DID NOT HAVE SPECIFICS REGARDING PTS OR WHEN EVENTS ACTUALLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PROFILER KIT CARDIAC MARKER KIT GJS ALERE SAN DIEGO INC 97100CP W48412B

    Patients

    Seq Age Sex Outcome Treatment
    1