BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110834 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01966
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE CARTRIDGE CAP ON THE ALANINE TRANSFERASE (ALT) REAGENT CARTRIDGE OF THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WAS SPLIT IN HALF IN PLACE ON CARTRIDGE HOWEVER THERE WAS NO OBVIOUS LEAKAGE FROM THE CARTRIDGE AND THE OPERATOR WAS NOT EXPOSED TO ANY FLUID. THE CUSTOMER DID NOT WANT TO USE THE REAGENT IN CASE PERFORMANCE WAS COMPROMISED BUT WAS OTHERWISE NOT CONCERNED. THEY DISPOSED OF THE CARTRIDGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1