BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1598989 · Received February 15, 2010

    Report

    Report Number
    2122870-2010-00039
    Event Type
    Death
    Date Received
    February 15, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK PERFORMED ON 01/15/2010 WAS WITHIN SPECIFICATIONS. THE CUSTOMER'S CUTOFF FOR A CRITICAL ACCUTNI RESULT IS >0.4NG/ML. 3. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A) THE FSE VERIFIED HARDWARE AND PERFORMED A PREVENTIVE MAINTENANCE (PM). B) THE FSE CONDUCTED A DIAGNOSTIC TESTING AND A 20 REPETITION PRECISION RUN; BOTH TESTS MET SPECIFICATIONS. THE BCI DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. NO MALFUNCTION IDENTIFIED. PATIENT RESULTS INDICATED A SIGNIFICANT RISK OF A CARDIAC EVENT, SUCH AS AMI OR DEATH. NO BLOCKAGE WAS DISCOVERED UPON CARDIAC CATHETERIZATION. HOWEVER, NON-DIAGNOSTIC RESULTS OF CARDIAC CATHETERIZATION IN AT-RISK PATIENTS ARE A RECOGNIZED LIMITATION OF THIS PROCEDURE. DUE TO THE CIRCUMSTANCES INVOLVED WITH THIS FEEDBACK, IT WAS DECIDED BY THE BCI TO FILE ON THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED REPRODUCIBLE TROPONIN (ACCUTNI) RESULTS IN THE RISK STRATIFICATION RANGE FOR ONE PATIENT: A) THREE SAMPLES COLLECTED FROM THE PATIENT ON TWO DIFFERENT DAYS GAVE ACCU TNI RESULTS IN THE RANGE OF 0.26-0.42NG/ML. B) THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SPECIMENS FROM THIS PATIENT WERE TESTED ON AN ALTERNATE METHODOLOGY AND TROPONIN RESULTS IN THE RANGE OF 8.48-12.8 (UNITS UNKNOWN) WERE GENERATED. CUSTOMER STATED THE PATIENT HAD A CARDIAC CATHETERIZATION WHICH DID NOT SHOW ANY BLOCKAGES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. TWO DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL AND DIED FROM A MASSIVE MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death