BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2132122 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02395
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY ANY QC INFORMATION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WAS PARTIALLY CLOSED UP AND WAS NOT ASPIRATING CORRECTLY. THE FSE REPLACED THE PROBE AND THE COLLAR WASH AND ALSO VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM WAS GENERATING LOW ANION GAPS ON SOME PATIENT SAMPLES. RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RUN ON AN ALTERNATE INSTRUMENT IN THE LABORATORY THAT PRODUCED HIGHER ANION GAP RESULTS AND WERE REPORTED. THE CUSTOMER COULD NOT IDENTIFY IF THE ISSUE WAS CAUSED BY SODIUM (NA), CHLORIDE (CL) AND/OR CARBON DIOXIDE (CO2). IT IS UNKNOWN IF THE DIFFERENCE IN THE NA, CL AND/OR CO2 EXCEEDED ASSAY PRECISION CLAIMS. THE CUSTOMER WAS UNABLE TO PROVIDE PATIENT RESULTS. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT AS NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 660I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1