BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PROFILER

    MDR report key: 2170660 · Received July 11, 2011

    Report

    Report Number
    2027969-2011-01512
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT TESTED RETAINED PROFILER (B)(4) WITH CALIBRATOR Z (NEGATIVE CONTROL) AND CALIBRATOR H (POSITIVE CONTROL) TO OBSERVED FOR TROPONIN RECOVERY. NO FALSE NEGATIVES OR LOW BIAS IN TNI RECOVERY WAS OBSERVED WITH ANY SAMPLES. NO ERROR CODES OR DEVICE ISSUES WERE OBSERVED. ONE DATA POINT WITH CALIBRATOR H WAS ABOVE THE MFG 2SD RANGE, WITH A PERCENT RECOVERY OF 106% (WITHIN THE MFG FINAL RELEASE SPECIFICATIONS). NO PT SAMPLE WAS RETURNED. PRODUCT SUPPORT WAS UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCES OR OTHER ENVIRONMENTAL FACTORS THAT ARE KNOWN TO AFFECT ANALYTE RECOVERY. ALL VALUES REPORTED BY THE CUSTOMER ON TRIAGE AND REFERENCE METHODS ARE BELOW THE CLINICAL CUTOFF FOR TNI OF 0.40NG/ML AS STATED IN THE PRODUCT INSERT. AS OF (B)(6) 2011, THERE HAS BEEN ONE COMPLAINT AGAINST PROFILER LOT W48393. 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 ONE PT TESTED ON THE TRIAGE CARDIAC PROFILER VERSUS ANOTHER DEVICE, (B)(4). PT WAS SEEN IN THE EMERGENCY DEPT (ED) ON (B)(6) 2011 AND WAS DIAGNOSED WITH CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER CARDIAC MARKER PANEL NBC ALERE SAN DIEGO, INC 97100CP W48402

    Patients

    Seq Age Sex Outcome Treatment
    1 NI