BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1932551 · Received December 18, 2010

    Report

    Report Number
    2050012-2010-01653
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) IS ON SITE AS OF (B)(4) 2010.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW SODIUM (NA) AND POTASSIUM (K) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY AN ER PHYSICIAN. UPON REPEAT, THE RESULTS WERE HIGHER AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER DOES NOT BELIEVE THERE WAS ANY IMPACT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1