BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS

    MDR report key: 2211046 · Received August 14, 2011

    Report

    Report Number
    2050012-2011-04273
    Event Type
    Malfunction
    Date Received
    August 14, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    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

    THE SAMPLES WERE SERUM. NO ADDITIONAL SAMPLE INFORMATION WAS PROVIDED. QC RUN PRIOR TO THE EVENT WAS LOW, HOWEVER THE CUSTOMER STATED IT WAS WITHIN THEIR LAB-ESTABLISHED RANGES. A BEC FIELD SERVICE ENGINEER (FSE) PERFORMED ELECTROLYTE INJECTION CUP MODIFICATION AND VERIFIED PERFORMANCE. A CLEAR ROOT CAUSE IS UNIDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED AND AMENDED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE LOW RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1