BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2032843 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00808
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 24, 2001
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC ON THE DAY OF THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. IT IS UNKNOWN IF THE QC PROVIDED BY THE CUSTOMER WAS PERFORMED BEFORE OR AFTER THE EVENT BECAUSE THE CUSTOMER COULD NOT SUPPLY ANY PATIENT DATA. A FIELD SERVICE ENGINEER (FSE) REPLACED THE CARBON BRIDGE AND PERFORMED MONTHLY CHLORIDE MAINTENANCE. THE FSE SERVICED THE ELECTROLYTE INJECTION CUP VALVE. THE FSE VERIFIED THE INSTRUMENT'S PERFORMANCE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THAT THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS GENERATED FALSE LOW ANION GAPS. WHEN THE LOW ANION GAPS WERE NOTICED, THE SAMPLES WERE REPEATED ON THE OTHER INSTRUMENT IN THE LAB, AND THOSE RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER DID NOT SUPPLY ANY EXAMPLES OF PATIENT RESULTS TO DEMONSTRATE WHICH ISE ANALYTES WERE CAUSING THE ISSUE. IT IS UNCLEAR IF INCORRECT RESULTS WERE REPORTED OUT OF THE LAB. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600

    Patients

    Seq Age Sex Outcome Treatment
    1