BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1911098 · Received November 30, 2010

    Report

    Report Number
    2122870-2010-00819
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LITHIUM HEPARIN PLASMA WITH GEL BARRIER. QC PERFORMED ON (B)(6) 2010 WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. LOW LEVEL QC TEST WAS OUT OF SPECIFICATION (HIGH). THE CUSTOMER RECALIBRATED THE UNIT AND RERAN THE TEST; HOWEVER, THE RESULT WAS STILL OUT OF SPECIFICATION (HIGH). A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH VALVE HOME SENSOR AND ROTOR. FSE REBUILT THE WASH PUMP, VERIFIED ALIGNMENTS AND CLEANED THE WASH WHEEL. ALL VERIFICATION TESTS MET SPECIFICATIONS. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ELEVATED ACCUTNI RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR TWO PATIENTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PATIENTS WERE HELD AT THE ER FOR OBSERVATION. REPEAT TESTING ON THE ORIGINAL SAMPLE GENERATED RESULTS WITHIN THE NORMAL REFERENCE RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization