BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIAGE CARDIOPROFILER TEST

    MDR report key: 2307986 · Received October 20, 2011

    Report

    Report Number
    2027969-2011-02178
    Event Type
    Death
    Date Received
    October 20, 2011
    Date of Event
    August 22, 2011
    Report Date
    October 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    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 PROFILER (B)(4) FOR A PREVIOUS COMPLAINT. OBSERVATIONS ARE FOR TNI RECOVERY. NO FALSE NEGATIVE OR LOW BIAS IN TNI RECOVERY WERE OBSERVED WITH THE POSITIVE CONTROL SAMPLE. NO DISCREPANT RESULT, FALSE POSITIVES, OR HIGH BIAS IN TNI RECOVERY WERE OBSERVED WITH ANY SAMPLE. THE PACKAGE INSERT FOR THE TRIAGE CARDIAC DEVICES STATES THAT THE CLINICAL CUT OFF FOR TROPONIN I (TNI) IS 0.40NG/ML. ALL VALUES OBTAINED BY THE CUSTOMER WERE BELOW 0.20NG/ML. BASED ON THE CLAIMS SPECIFIED IN THE PACKAGE INSERT NO POSITIVE TNI RESULTS WERE OBSERVED. 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. THIS ISSUE WILL BE TRACKED AND TRENDED TO DETECT ANY FURTHER OCCURRENCE. AS OF (B)(6) 2011, THERE ARE (B)(4) COMPLAINTS AGAINST THIS DEVICE LOT, ONE OF WHICH IS FOR TNI RECOVERY. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POSSIBLE FALSE POSITIVE TROPONIN I (TNI) RESULT ON TRIAGE CARIOPROFILER KIT. NO COMPARABLE DATA FROM THE LAB WAS PROVIDED. ACCORDING TO DATA RECEIVED FROM THE CUSTOMER, THIS PT DIED THREE DAYS AFTER THE SAMPLE DRAW ON (B)(6) 2011. THE TRIAGE TNI RESULT WAS POSITIVE BUT NO LAB DATA WAS PROVIDED AS A COMPARISON TO THE TRIAGE TROPONIN I RESULT. IT IS UNCLEAR WHETHER THE TRIAGE RESULTS CONTRIBUTED TO THE ADVERSE EVENT. IT WAS NOTED THAT THE PT HAD RESPIRATORY FAILURE AND DIED. IT WAS ALSO NOTED THAT THE PT HAD ASPIRATION PNEUMONIA. NO FURTHER PT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIOPROFILER TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97100CP W49548

    Patients

    Seq Age Sex Outcome Treatment
    1 Death