BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX/LX ALT REAGENT KIT

    MDR report key: 2032993 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00909
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE WAS PERFORMED. NO ADDITIONAL INFORMATION WAS SUPPLIED BY THE CUSTOMER.

    Description of Event or Problem · 1

    UPON RECEIVING A SHIPMENT OF SYNCHRON CX/LX ALT REAGENT AT A BECKMAN COULTER INC. (BCI) FACILITY, IT WAS REPORTED THAT ONE (1) OF THE KITS HAD A BROKEN AND LEAKING BOTTLE. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX/LX ALT REAGENT KIT CX/LX ALT REAGENT KIT CKA BECKMAN COULTER INC. N/A M011513

    Patients

    Seq Age Sex Outcome Treatment
    1