BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LD 2 X 300

    MDR report key: 2080703 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01298
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CFJ
    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

    REPLACEMENT KIT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A REAGENT LEAK FROM SYNCHRON LD CARTRIDGE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LD 2 X 300 LACTATE DEHYROGENASE ENZYME TEST SYSTEM CFJ BECKMAN COULTER, INC. NA Z101228

    Patients

    Seq Age Sex Outcome Treatment
    1