BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® GGT KIT

    MDR report key: 1936586 · Received December 22, 2010

    Report

    Report Number
    2050012-2010-01722
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQB
    PMA / PMN Number
    K971333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE SYNCHRON CX/LX GGT KIT WAS LEAKING DUE TO THE POOR QUALITY OF THE CARTRIDGE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® GGT KIT GAMMA-GLUTAMYL TRANSFERASE KIT JQB BECKMAN COULTER INC. GGT KIT Z006038

    Patients

    Seq Age Sex Outcome Treatment
    1