BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 1821440 · Received August 27, 2010

    Report

    Report Number
    2027969-2010-01295
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DAP
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING FALSE POSITIVE TROPONIN I (TNI) RESULTS ON TRIAGE PROFILER SOB PANEL VS BECKMAN AND ANOTHER INSTRUMENT (NAME NOT SPECIFIED). PT WAS STILL WAITING FOR HER EST TODAY, BUT HAS 2 NEGATIVE TROPONIN RESULTS. THE VENOUS WHOLE BLOOD SAMPLES WERE COLLECTED IN AN EDTA TUBE 5 MINS BEFORE TESTING, AND KEPT AT ROOM TEMP. THE DEVICES WERE AT ROOM TEMP WHEN TESTED AND THE CORRECT SAMPLE VOLUME WAS ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST DAP ALERE SAN DIEGO, INC. 97300 W47490B

    Patients

    Seq Age Sex Outcome Treatment
    1