BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1903991 · Received November 20, 2010

    Report

    Report Number
    2050012-2010-01359
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES BUT SHOWED EVIDENCE OF IMPRECISION. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SOME HARDWARE COMPONENTS INCLUDING WASH COLLAR AND MODULAR CHEMISTRY PROBE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DRIFTING ISE (ION SELECTIVE ELECTRODE) RESULTS GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND HAD TO BE AMENDED. THE CUSTOMER STATED THAT THE PATIENT TREATMENT WAS IMPACTED, BUT THEY DO NOT KNOW IF THE PATIENT WAS HARMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1