BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2213521 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04275
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. NO ADDITIONAL INFORMATION AS PROVIDED. PER THE CUSTOMER, QC RUN PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QA REVIEW OF THE QC SHOWS THAT THE LAB'S RANGES ARE WIDE, AND QC DID EXHIBIT IMPRECISION IN THE DAYS PRIOR TO THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) FOUND A BUBBLE ON THE CO2 MEASURING ELECTRODE. THE FSE REPLACED THE ELECTRODE AND MEMBRANE AND VERIFIED PERFORMANCE.

    Additional Manufacturer Narrative · 1

    CHANGE FROM: THE SAMPLE WAS SERUM. NO ADDITIONAL INFORMATION AS PROVIDED. TO: THE SAMPLE WAS SERUM, COLLECTED IN SST TUBES AND LITHIUM HEPARIN TUBES AND SPUN DOWN FOR 10 MINUTES.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO INSTRUMENT GENERATED INTERMITTENT ERRONEOUS CO2 RESULTS. ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE ALTERNATE DXC IN THE LAB AND THE OBTAINED RESULT WAS REPORTED. PATIENT RESULTS ARE PROVIDED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR