BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1918725 · Received December 9, 2010

    Report

    Report Number
    2050012-2010-01543
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB'S ESTABLISHED RANGES, BUT NO DATA WAS RECEIVED FROM THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE DECONTAMINATED THE ISE SYSTEM, REPLACED THE CARBON BRIDGE, AND PERFORMED A PREVENTIVE MAINTENANCE (PM). AS OF (B)(6) 2010, THERE ARE NO FURTHER REPORTS FROM THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING RANDOM FALSE HIGH SODIUM (NA) RESULTS GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM ON THE NIGHT SHIFT OF (B)(6) 2010. THE CUSTOMER ONLY SUPPLIED ONE EXAMPLE: NA RESULT OF 151MMOL/L WAS REPEATED ON A DIFFERENT INSTRUMENT AND RECOVERED 136MMOL/L. NO FALSE HIGH RESULTS WERE REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1