BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1955356 · Received January 10, 2011

    Report

    Report Number
    2050012-2011-00096
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE INCIDENT AND THE RESULTS WERE ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) FOUND DEPOSIT ON THE REAGENT SYRINGE. FSE REPLACED THE NEW MODULAR CHEMISTRY REAGENT SYRINGE AND THE CREM MODULE. THE FOLLOWING MED-WATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2011-00107.

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE INCIDENT AND THE RESULTS WERE ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) FOUND DEPOSIT ON THE REAGENT SYRINGE. FSE REPLACED THE NEW MODULAR CHEMISTRY REAGENT SYRINGE AND THE CREM MODULE. THE FOLLOWING MED-WATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2011-00107. (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH CREATININE (CREM) RESULTS FOR TWO PATIENTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULT OF PATIENT ONE WAS REPORTED OUT OF THE LABORATORY. RESULT OF PATIENT TWO WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. AMENDED REPORT WAS INITIATED FOR PATIENT NUMBER ONE ONLY. PATIENT NUMBER ONE'S RESULTS WILL BE COVERED UNDER MDR 2050012-2011-00107. TREATMENT WAS NOT INITIATED OR WITHHELD FOR PATIENT NUMBER TWO.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH CREATININE (CREM) RESULTS FOR TWO PATIENTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULT OF PATIENT ONE WAS REPORTED OUT OF THE LABORATORY. RESULT OF PATIENT TWO WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. AMENDED REPORT WAS INITIATED FOR PATIENT NUMBER ONE ONLY. PATIENT NUMBER ONE'S RESULTS WILL BE COVERED UNDER MDR 2050012-2011-00107. TREATMENT WAS INITIATED OR WITHHELD FOR PATIENT NUMBER TWO.

    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 76 YR