BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® GGT REAGENT

    MDR report key: 2093928 · Received May 18, 2011

    Report

    Report Number
    2050012-2011-01694
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JIX
    PMA / PMN Number
    K971333
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT REPLACEMENT REAGENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), TO REPORT THAT GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) CARTRIDGE SPLIT AT BASE AND REAGENT LEAKED THROUGH THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® GGT REAGENT SYNCHRON® GGT REAGENT JIX BECKMAN COULTER INC. N/A M003643

    Patients

    Seq Age Sex Outcome Treatment
    1