BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2200680 · Received July 27, 2011

    Report

    Report Number
    2027969-2011-01658
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. PROFILER W48340 WAS PREVIOUSLY TESTED AND REVEALED NO LOW BIAS OR FALSE NEGATIVE RESULTS WITH POSITIVE CONTROL SAMPLES. PRODUCT SUPPORT'S OBSERVATIONS FOR TROPONIN RECOVERY WERE AS FOLLOWS: NO FALSE POSITIVES OR HIGH BIAS IN RECOVERY WAS OBSERVED WITH ANY SAMPLE. PT SAMPLE 1 ON TRIAGE WAS <0.05NG/ML AND 0.00NG/ML ON ACCESS2, NO DISCREPANT RESULTS OBSERVED. PT SAMPLE 2 ON TRIAGE WAS <0.05NG/ML AND WAS 0.00NG/ML ON ACCESS2, NO DISCREPANT RESULTS OBSERVED WITH SAMPLE 2. ALL DATA POINTS WITH NEGATIVE CONTROL CALIBRATOR Z WERE BELOW THE MFG CUT OFF. ONE DATA POINT WITH POSITIVE CONTROL CALIBRATOR H WAS BELOW THE MFG 2SD RANGE, WITH A PERCENT RECOVERY OF 86%. NO ERROR CODES OR DEVICE ISSUES WERE OBSERVED. NO HIGH BIAS OR FALSE POSITIVES WERE OBSERVED WITH ANY SAMPLE. PRODUCT SUPPORT WAS UNABLE TO DETERMINE CAUSE OF CUSTOMER'S FALSE NEGATIVE RESULT. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE TROPONIN ON THE TRIAGE CARDIO PROFILER VERSUS ANOTHER DEVICE, THE ACCESS 2. A (B)(6) YR OLD PT ARRIVED AT THE EMERGENCY UNIT WITH PAIN. TREATMENT OF PT UNK. BIOLOGIST RAN BLOOD EDTA ON THE TRIAGE METER AND HEPARIN PLASMA ON THE ACCESS 2. BIOLOGIST CALLED THE PHYSICIAN TO EXPLAIN THE SITUATION, BUT PHYSICIAN DID NOT WAIT FOR RESULTS BECAUSE PT HAD AN INFARCTION. BIOLOGIST RAN ANOTHER TEST ON THE TRIAGE METER AND RESULTS WERE STILL NEGATIVE FOR TROPONIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC PANEL MARKER NBC ALERE SAN DIEGO, INC 97100CP W48340B

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening