BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2173454 · Received July 23, 2011

    Report

    Report Number
    2050012-2011-03342
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, QC HAD BEEN WITHIN LAB-ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE INSTRUMENT AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM GENERATED ELECTROLYTE AND ANION GAP RESULTS THAT DID NOT MATCH THE RESULTS OBTAINED FROM A DIFFERENT INSTRUMENT. DATA WAS REQUESTED, BUT NOT PROVIDED BY THE CUSTOMER. PATIENT RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1