BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1880411 · Received October 22, 2010

    Report

    Report Number
    2050012-2010-01034
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT, ISE QC RESULTS WERE WITHIN LAB'S ESTABLISHED RANGES. THERE WERE INTERMITTENT INSTRUMENT FLAGS FOR ISE RATIO PUMP ERRORS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REBUILT THE RATIO PUMP. AS OF (B)(6) 2010, THERE WERE NO FURTHER CALLS TO THE BCI HOTLINE FOR ISE PROBLEMS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CARBON DIOXIDE (CO2), AND CALCIUM (CA) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM. AT TIMES ERRONEOUSLY LOW CA RESULTS WERE GENERATED BY THE ANALYZER. THERE WAS NO AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX® I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX®I 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1