BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1896765 · Received November 10, 2010

    Report

    Report Number
    2050012-2010-01224
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAD THE ORIGINAL CREATININE (CRE) MODULE WITH THE OLDER STYLE STIRRER MOTOR. A FIELD SERVICE ENGINEER (FSE) REPLACED THE ENTIRE CRE MODULE. THE PART WILL BE RETURNED FOR INVESTIGATION THE FOLLOWING MED-WATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2010-00956, 2050012-2010-01222, 2050012-2010-01223, 2050012-2010-01225, 2050012-2010-01226. REMOVE: CTS PERFORMED TROUBLESHOOTING; 2050012-2010-01227. CHANGE: FROM NOTIFICATION TO INSPECTION.

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAD THE ORIGINAL CREATININE (CRE) MODULE WITH THE OLDER STYLE STIRRER MOTOR. A FIELD SERVICE ENGINEER (FSE) REPLACED THE ENTIRE CRE MODULE. THE PART WILL BE RETURNED FOR INVESTIGATION THE FOLLOWING MED-WATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2010-00956, 2050012-2010-01222, 2050012-2010-01223, 2050012-2010-01225, 2050012-2010-01226, 2050012-2010-01227.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FIVE FALSE LOW CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND HIGHER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. UNKNOWN IF PATIENT TREATMENT WAS INITIATED OR WITHHELD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FIVE FALSE LOW CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND HIGHER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. UNKNOWN IF PATIENT TREATMENT WAS INITIATED OR WITHHELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR