BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1747193 · Received July 6, 2010

    Report

    Report Number
    2050012-2010-00383
    Event Type
    Malfunction
    Date Received
    July 6, 2010
    Date of Event
    April 12, 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 A REPLACEMENT FOR THE REAGENT PACKS.

    Description of Event or Problem · 1

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

    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. NA MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1