BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2080531 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01396
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE CUSTOMER DID NOT PROVIDE DATA, BCI WAS UNABLE TO EVALUATE IF THE VALUES EXCEEDED PRECISION CLAIMS. PER CUSTOMER, QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) VISUALLY INSPECTED THE INSTRUMENT AND NO ISSUES WERE NOTED. THE CUSTOMER DECLINED ISE HEALTH CHECKS TO BE PERFORMED BY THE FSE. FSE PERFORMED 12 RANDOM SAMPLE CORRELATIONS WITH ALTERNATE INSTRUMENTS. THE RESULTS WERE ACCEPTABLE. ROOT CAUSE IS UNKNOWN. THE ALTERNATE INSTRUMENT IS COVERED UNDER MDR 2050012-2011-01397.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INSTRUMENT UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED LOW ANION GAPS. ALTHOUGH, THE ISSUE COULD HAVE BEEN CAUSED BY NA, CL, OR CO2; THE CUSTOMER COULD NOT SPECIFY WHICH ION SELECTIVE ELECTRODE (ISE) ANALYTES CAUSED THE ISSUE. RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE CUSTOMER DID NOT PROVIDE DATA.

    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. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1