BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 1079304 · Received July 18, 2008

    Report

    Report Number
    2050012-2008-00031
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN LITHIUM HEPARIN TUBES. ON (B) (6), THE INSTRUMENT WAS GIVING OBSTRUCTION DETECTION ERRORS FOR THE CARTRIDGE CHEMISTRIES (CC) SAMPLE PROBE. THE CUSTOMER CALLED CUSTOMER TECHNICAL SERVICE (CTS), AND THEY ATTEMPTED TO RESOLVE THE ISSUE, BUT WERE UNABLE TO DO SO. THE OBSTRUCTION DETECTION FEATURE WAS DISABLED TO ALLOW THE CUSTOMER TO CONTINUE RUNNING CC. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB ON (B) (6) 2008: THE FSE INSPECTED THE INSTRUMENT AND FOUND OBSTRUCTION IN THE CC SAMPLE PROBE. THE FSE REPLACED THE OBSTRUCTION DETECTION TRANSDUCER, THE CC SAMPLE PROBE AND, AS A PRECAUTION, THE 3-WAY VALVE. AFTER SERVICE, THE INSTRUMENT OPERATED WITHIN SPECIFICATIONS. ON A RECUR EVENT, ANY CARTRIDGE CHEMISTRY COULD BE AFFECTED. TREATMENT INITIATED OR WITHHELD BASED ON ERRONEOUS RESULTS COULD CONTRIBUTE TO SERIOUS INJURY. OBSTRUCTION IN THE CC SAMPLE PROBE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS RESULTS FOR CARTRIDGE CHEMISTRIES (CC) GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM. FOUR PT SAMPLES GAVE ERRONEOUS RESULTS FOR SEVERAL CHEMISTRIES. THE INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LAB BECAUSE THEY DID NOT MATCH PREVIOUS PT VALUES. THE AFFECTED SAMPLES WERE RE-TESTED AND CORRECT RESULTS WERE OBTAINED. NO PT TREATMENTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA