BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2213004 · Received August 8, 2011

    Report

    Report Number
    2027969-2011-01756
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    August 8, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE NOT RETURNED FOR INVESTIGATION. PRODUCT SUPPORT TESTED PROFILER LOT #W48418 WITH POSITIVE CONTROLS, CALIBRATORS G AND H AND TWO NORMAL WHOLE BLOOD DONORS FOR TROPONIN RECOVERY. NO FALSE NEGATIVE RESULTS OR ERROR CODES WERE OBSERVED. ALL DATA POINTS WITH CALIBRATOR H WERE WITHIN THE MANUFACTURING 2SD RANGE WITH A PERCENT RECOVERY OF (B)(4), WHICH WAS ALSO WITHIN THE MANUFACTURING FINAL RELEASE SPECIFICATIONS. ALL DATA POINTS WITH CALIBRATOR G WERE ABOVE 0.40 NG/ML AND NO FALSE NEGATIVE RESULTS WERE OBSERVED. PRODUCT SUPPORT DID NOT OBSERVE CUSTOMER'S COMPLAINT OF FALSE NEGATIVE TNI DURING RETAINED TESTING WITH EITHER OF THE POSITIVE CONTROL SAMPLES. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTORS THAT MAY HAVE AFFECTED ANALYTE RECOVERY. (B)(4). THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE TROPONIN (TNI) ON THE TRIAGE CARDIO PROFILER VERSUS A LAB ANALYZER, DADE DIMENSION. A (B)(6) PT ARRIVED AT THE HOSPITAL WITH COMPLAINTS OF PAIN ON THE SIDE. AN EKG WAS ALSO PERFORMED AND THE PT'S FINAL DIAGNOSIS WAS NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER PANEL NBC ALERE SAN DIEGO, INC 97100CP W48418B

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other