BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® IRON / TIBC CALIBRATOR

    MDR report key: 2182574 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03859
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED A SYNCHRON IRON/IBCT CALIBRATOR THAT WAS LEAKING FROM A LOOSE CAP. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® IRON / TIBC CALIBRATOR LIPASE TEST SYSTEM CKA BECKMAN COULTER, INC. NA 0206071

    Patients

    Seq Age Sex Outcome Treatment
    1