BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIOPROFILER TEST

    MDR report key: 2243893 · Received July 29, 2011

    Report

    Report Number
    2027969-2011-01685
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 29, 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

    TESTING OF PROFILER W48400 WAS PREVIOUSLY CONDUCTED WITH TWO OTHER COMPLAINTS. NO FALSE NEGATIVE OR LOW BIAS IN TNI RECOVERY WAS 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. NO LOW BIAS OR FALSE NEGATIVE RESULTS WERE OBSERVED. (B)(4). NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE TROPONIN I (TNI) RESULTS ON TRIAGE VS BECKMAN ACCESS. A FEMALE, BIRTH YEAR (B)(6), VISITED THE ED ON (B)(6) 2011. A SAMPLE WAS RUN ON TRIAGE CARDIOPROFILER WITH NEGATIVE RESULTS WHICH DID NOT AGREE WITH ELEVATED OTHER CARDIAC MARKERS. A SAMPLE WAS RUN IN THE LAB USING THE BECKMAN ACCESS WITH A POSITIVE RESULT. CUSTOMER DOES NOT THINK PT HAD ANY INVASIVE PROCEDURE DONE. NO REFERRAL TO CARDIOLOGIST. DISCHARGE DIAGNOSIS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIOPROFILER TEST CARDIAC MARKER TEST GJS ALERE SAN DIEGO, INC. 97100CP W48404B

    Patients

    Seq Age Sex Outcome Treatment
    1