BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2046481 · Received April 9, 2011

    Report

    Report Number
    2050012-2011-00957
    Event Type
    Malfunction
    Date Received
    April 9, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF QC DATA SENT INDICATES QC WAS WITHIN 2SD FOR PREVIOUS MONTH. QC WAS HIGHER THAN 2SD FOR LEVEL I AND II ON THE DAY OF EVENT. A FIELD SERVICE (FSE) WAS DISPATCHED AND VERIFIED ALL GLUCOSE HARDWARE AND SAMPLE HANDLING HARDWARE. NO HARDWARE WAS REPLACED. THE FSE PERFORMED CALIBRATION AND QC WITH ACCEPTABLE RESULTS. SYSTEM TECHNICAL SUPPORT (STS) PERFORMED SOME SERVICE AND CONTINUES TO WORK WITH THE FSE. ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT ONE ERRONEOUSLY LOW GLUCOSE (GLUCM) RESULT WAS GENERATED WHEN RUNNING IN DUPLICATE MODE ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE SPECIMEN WAS RE-TESTED ON A DIFFERENT INSTRUMENT AND OBTAINED RESULTS CONFIRMED THE HIGHER RESULT. THE LOW RESULT WAS NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1