BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1172634 · Received September 11, 2008

    Report

    Report Number
    2050012-2008-00049
    Event Type
    Other
    Date Received
    September 11, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC SAMPLE INFORMATION WAS PROVIDED. QC WAS LOW IN 2008 AND OTHER CHEMISTRY CALIBRATION ISSUES WERE REPORTED. FOUR DAYS LATER, A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE: FSE FOUND THE REAGENT CAROUSEL NOT HOLDING ALIGNMENT, AND REPLACED IT. TWO DAYS LATER, FSE VISITED AGAIN AND RAN PVT TESTS. SAMPLE PROBE CARRYOVER TESTING FAILED AND THE SAMPLE PROBE AND WASH COLLAR WERE REPLACED. THE REPAIRS SEEM TO HAVE RESOLVED THE ISSUE. TREATMENT WAS NOT AFFECTED IN THIS EVENT, AS THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ON RECUR; ANY CARTRIDGE CHEMISTRY RESULT COULD BE AFFECTED. TREATMENT INITIATED OR WITHHELD BASED ON ERRONEOUSLY LOW RESULTS COULD CONTRIBUTE TO SERIOUS INJURY. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING ERRONEOUSLY LOW CK RESULTS PRODUCED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS. THE ORIGINAL RESULT WAS 25IU/L WHICH REPEATED AT 124IU/L AND WHEN TESTED ON A DIFFERENT INSTRUMENT, IT GAVE A RESULT OF 123IU/L. A SAMPLE OBTAINED FROM ANOTHER PATIENT GAVE A CK RESULT OF 13IU/L UPON TESTING AND WHEN REPEATED IT GAVE A RESULT OF 41IU/L. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO AFFECT TO PATIENT OR USER WITH REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA