BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1883641 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01066
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 26, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO AND AFTER THE EVENT, ISE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE FLUSHED THE MC (MODULAR CHEMISTRY) SAMPLE PROBE AND CHECKED THE ALIGNMENT. THE MC SAMPLE SYRINGE WAS CLEANED AND THE PLUNGER WAS REPLACED. THE FSE ALSO CLEANED THE FLOW CELL AND A SMALL PIECE OF RED RUBBER WAS FOUND ON THE EIC (ELECTROLYTE INJECTION CUP) LEFT VALVE FLAPPER. THE EIC CUP AND VALVES WERE ALSO CLEANED. TROUBLESHOOTING AND INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND ON THE ORIGINAL INSTRUMENT, PRODUCING LOWER RESULTS, WHICH WERE REPORTED OUT. THERE WAS NO AFFECT TO PATIENT TREATMENT.

    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