BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3230616 · Received July 16, 2013

    Report

    Report Number
    2050012-2013-00463
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE REPLACED THE CARTRIDGE CHEMISTRY SAMPLE PROBE AND LEVEL SENSE BOARD (SMART MODULE) TO RESOLVE THE ISSUE. THE TWO PARTS ARE INVOLVED IN CARTRIDGE CHEMISTRY SAMPLE HANDLING AND CAN AFFECT ANY CARTRIDGE CHEMISTRY ASSAY. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO HARDWARE; THE FSE REPLACED THE CARTRIDGE CHEMISTRY SAMPLE HANDLING COMPONENTS TO RESOLVE THE ISSUE. RESULTS: LEVEL SENSE BOARD (SMART MODULE). ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2050012-2013-00463, 2050012-2013-00464.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW AND SUPPRESSED CC (CARTRIDGE CHEMISTRIES) RESULTS FOR MULTIPLE PATIENTS, OVER TWO (2) DIFFERENT DAYS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPORTED THAT THE INSTRUMENT ALSO GENERATED LEVEL SENSE ERRORS DURING THIS EVENT. THE CUSTOMER PROVIDED INSTRUMENT PRINTOUTS FOR SIX (6) PATIENTS AND ONE (1) VERBAL EXAMPLE. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE SEE MEDWATCH #2050012-2013-00464 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) RESULTS WERE WITHIN THE ESTABLISHED RANGES ON THE DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330046 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1