BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1871795 · Received October 16, 2010

    Report

    Report Number
    2122870-2010-00621
    Date Received
    October 16, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR TESTING. QC WAS WITHIN THE CUSTOMERS ESTABLISHED RANGES PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED HARDWARES ON THE UNIT. FSE ALSO PERFORMED A SYSTEM CHECK, CARRYOVER, AND HIGH SENSITIVITY SYSTEM CHECK AND ALL TESTS MET SPECIFICATIONS. A CLEAR ROOT CAUSE IS UNDETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ELEVATED ACCUTNL RESULT IN THE RISK STRATIFICATION RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE SAMPLE WAS REPEATED AND NORMAL REFERENCE RANGE RESULT WAS OBTAINED. THE ELEVATED RESULT WAS SUBMITTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1