BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS

    MDR report key: 2210989 · Received August 13, 2011

    Report

    Report Number
    2050012-2011-04271
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM. NO ADDITIONAL SAMPLE INFORMATION WAS PROVIDED. PER CUSTOMER, QC RUN PRIOR TO THE EVENT WAS WITHIN LABORATORY ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT. A BEC FIELD SERVICE ENGINEER REPLACED A CRACKED ELECTROLYTE INJECTION CUP VALVE AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS CHLORIDE RESULTS GENERATED ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED. WHEN ANION GAPS FLAGGED THE SAMPLES, THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT, AND THOSE RESULTS REPORTED. THE CUSTOMER COULD NOT PROVIDE ACTUAL RESULTS OR VERBAL EXAMPLES. THE NUMBER OF SAMPLES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1