BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1799781 · Received August 13, 2010

    Report

    Report Number
    2122870-2010-00441
    Date Received
    August 13, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LI HEPARIN PLASMA, WHICH WERE CENTRIFUGED FOR 5 MINUTES IN THE STAT SPIN. QC IS ANALYZED ONCE PER DAY AND WAS WITHIN THE CUSTOMERS ESTABLISHED RANGES DURING THE EVENT. ON (B)(4) 2010 THE CUSTOMER PERFORMED SYSTEM CHECK AND IT WAS WITHIN INSTRUMENT SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED DIAGNOSTIC SYSTEM CHECK. THE WASHED PORTION FAILED. THE FSE ALSO PERFORMED PM AND DIAGNOSTIC TEST, WHICH PARTIALLY FAILED. FSE REPLACED THE PERI PUMP TUBING, MADE ADJUSTMENT, AND REPEATED THE DIAGNOSTIC TEST, WHICH MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI RESULTS FOR TWO PATIENTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. IN ADDITION, A THIRD PATIENT SAMPLE RESULTED IN THE RISK STRATIFICATION RANGE. THE RESULT FOR PATIENT NUMBER TWO WAS REPORTED OUT OF THE LABORATORY. FOR PATIENTS 1 AND 3, A SECONDARY SAMPLE WAS RUN ON THE SAME UNIT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. FOR PATIENT #2 THE SAMPLE WAS REPEATED ON ANOTHER UNIT AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. AMENDED REPORT WAS INITIATED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1