BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2552410 · Received April 29, 2012

    Report

    Report Number
    2050012-2012-01003
    Event Type
    Malfunction
    Date Received
    April 29, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ALL MODULAR CHEMISTRIES CUPS ON THE MODULAR CHEMISTRY (MC) SIDE OF THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM WERE OVERFLOWING. CUSTOMER REPORTED THAT SMALL AMOUNTS OF ALBUMIN (ALBM), BLOOD UREA NITROGEN (BUNM), CREATININE (CREM), GLUCOSE (GLUM), PHOSPHORUS (PHOSM), AND TOTAL PROTEIN (TPM) WERE OVERFLOWING FROM THE TOPS OF THE CUPS. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND DEBRIS FROM THE MC WASTE MANIFOLD. THE FSE FLUSHED THE MANIFOLD WITH BLEACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1