BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1842966 · Received September 23, 2010

    Report

    Report Number
    2050012-2010-00831
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE GLUCOSE CUP WHICH REDUCED THE IMPRECISION. FSE REPLACED THE GLUCOSE MODULE, WHICH IMPROVED PRECISION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT INCONSISTENT GLUCOSE MODULAR RESULTS WHEN PERFORMING PATIENT SAMPLE POOL OF APPROXIMATELY 100 MG/ML USING UNICEL DXC 800 PRO CHEMISTRY ANALYZER. NO SPECIFIC RESULTS WERE PROVIDED. PATIENT TREATMENT WAS NOT IMPACTED WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1