BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WASH CONCENTRATE II, LX CREATININE, KIT ISE

    MDR report key: 1836058 · Received September 15, 2010

    Report

    Report Number
    2050012-2010-00723
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT SYSTEM ISSUE. REPLACEMENTS WERE SENT TO CUSTOMER. ADDITIONAL INFORMATION: REAGENT DATE OF MFG: WASH CONCENTRATE II-06/29/2010; LX CREATININE-05/27/2010; KIT, ISE REFERENCE-05/28/2010. PRODUCT CODE FOR LX CREATININE-CGX. PRODUCT CODE FOR WASH CONCENTRATE II AND KIT, ISE REFERENCE IS PROVIDED (LDT).

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) STATING THAT THE BOTTLE CAP WASN'T FASTENED DOWN, AND THE LEAKAGE WAS FOUND WHEN UNLOADING THE FOLLOWING REAGENTS: WASH CONCENTRATE II, LX CREATININE, AND ISE KIT. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WASH CONCENTRATE II, LX CREATININE, KIT ISE WASH CONCENTRATE II, LX CREATININE, KIT ISE LXG BECKMAN COULTER INC. Z006010/Z005027/Z005031

    Patients

    Seq Age Sex Outcome Treatment
    1