BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2030009 · Received March 25, 2011

    Report

    Report Number
    2050012-2011-00809
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. PRIOR TO SERVICE ARRIVAL, THE CUSTOMER CHANGED THE REAGENT STRAWS, REPLACED THE CO2 MEMBRANE AND BLEACHED THE FLOW CELL PER BCI PROCEDURE. THIS RESOLVED THE ISSUE. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. PERFORMANCE TESTING FAILED SPECIFICATIONS AND FSE REPLACED THE CO2 ALKALINE BUFFER PERI PUMP. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE HIGH CARBON DIOXIDE (CO2) RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS ON ONE PATIENT SAMPLE. WHEN THE ANION GAP ALERTED THE LAB OF THE ISSUE, THE SAMPLE WAS RERUN ON THE OTHER INSTRUMENT IN THE LAB. THE REPEATED RESULT WAS MORE BELIEVABLE AND WAS REPORTED OUT OF THE LAB. THE INSTRUMENT SUPPRESSED THE CO2 RESULT AND DID NOT REPORT A VALUE FOR ONE OTHER SAMPLE. ONLY CO2 WAS AFFECTED. THE HIGH 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 JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1