BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    MDR report key: 1905198 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01376
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    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 FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED SOME HARDWARE COMPONENTS INCLUDING 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) REGARDING AN ELEVATED SODIUM (NA) RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMS FOR ONE PATIENT. THE INITIAL NA RESULT OF 160MMOL/L WAS REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED AND A RESULT OF 136MMOL/L WAS OBTAINED. THE RESULT WAS 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 SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1