BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1953099 · Received January 7, 2011

    Report

    Report Number
    2122870-2011-00008
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCUTNI SAMPLES ARE COLLECTED IN PLASTIC BD LITHIUM HEPARIN PLASMA TUBES. ACCUTNI QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER SENT PATIENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS TREATED THE SAMPLE WITH INTERFERENCE ELIMINATING PROTEINS. NONE OF THE PROTEINS SUCCEEDED IN SIGNIFICANTLY ALTERING THE DOSE COMPARED TO THE NEAT VALUE. DILUTION TESTING WAS ALSO PERFORMED ON THE SAMPLE WHICH DILUTED VERY LINEARLY. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING REPRODUCIBLE ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE AMI CUT OFF, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS REDRAWN DUE TO THE INITIAL ELEVATED RESULT BEING QUESTIONED BY THE PHYSICIAN.

    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 83 YR Other