BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1747360 · Received July 6, 2010

    Report

    Report Number
    2050012-2010-00410
    Event Type
    Malfunction
    Date Received
    July 6, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENTS FOR THE REAGENT PACKS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT AN AMYLASE (AMY), MAGNESIUM (MG), CREATINE KINASE (CK) AND TOTAL BILIRUBIN (TBIL) REAGENT PACK LEAKED. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1