BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2080882 · Received May 7, 2011

    Report

    Report Number
    2050012-2011-01435
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE COLLECTION AND STORAGE. QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. SYSTEM STARTED SUPPRESSING CO2 RESULTS. CUSTOMER ATTEMPTED TO RECALIBRATE BUT CALIBRATION FAILED. CUSTOMER FOUND THAT THE ALKALINE BUFFER BOTTLE WAS EMPTY AND FLUID WAS LEAKING FROM THE CO2 ALKALINE BUFFER INLINE FILTER. PER HOTLINE INSTRUCTIONS, CUSTOMER REPLACED THE FILTER AND REAGENT WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A FALSE LOW CO2 RESULT OF 18 MMOL/L FOR ONE (1) PATIENT, GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THIS RESULT WAS REPORTED OUT OF THE LAB. REPEAT TESTING OF THE SAMPLE ON AN ALTERNATE INSTRUMENT GENERATED A CO2 RESULT OF 23 MMOL/L. THE REPORT WAS AMENDED WITH THIS RESULT. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1