BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN SYNCHRON TRIGLYCERIDES REAGENT

    MDR report key: 2628405 · Received June 26, 2012

    Report

    Report Number
    2050012-2012-01319
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CDT
    PMA / PMN Number
    K915084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCLUDED IN THIS PACKAGE WAS A CONTAINER FOR BECKMAN SYNCHRON TRIGLYCERIDES REAGENT. THERE IS NO INFORMATION TO INDICATE WHETHER ALL OR ANY OF THE ENCLOSED PRODUCTS LEAKED. THE PRODUCT WAS RETURNED IN A SALVAGE DRUM AND INSIDE A POLY BAG. THE PRODUCTS INCLUDED IN THE PACKAGE WERE THE FOLLOWING: CX TRIGLYCERIDE REAGENT 2 X 300 TEST: P/N (B)(4), LOT M112262, MANUFACTURING (MFG) DATE: 01/24/2012, EXPIRATION (EXP) DATE: 07/31/2013; CX/LX LIP KIT 2 X 60 TEST: P/N (B)(4), LOT M111230, MFG DATE: 01/25/2012, EXP DATE: 07/31/2013; CX/LX ALP KIT 2 X 400 TEST: P/N (B)(4), LOT M201203, MFG DATE: 02/09/2012, EXP DATE: 08/31/2013; CX/LX ALT KIT 2 X 400 TEST: P/N (B)(4), LOT M112250, MFG DATE: 02/10/2012, EXP DATE: 08/31/2013. HDL DIRECT 2 X 200 TEST CARTRIDGE: P/N (B)(4), LOT M112244, MFG DATE: 01/17/2012, EXP DATE: 07/31/2013. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER REPRESENTATIVE REPORTED THAT A SHIPPING PACKAGE WAS RETURNED BY THE CARRIER AS DAMAGED WITH A COMMENT THAT READ "PRODUCT WAS LEAKED UPON." THE PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT) WAS USED WHEN HANDLING THE PRODUCT. NO ONE CAME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN SYNCHRON TRIGLYCERIDES REAGENT LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES CDT BECKMAN COULTER, INC. NA M112262

    Patients

    Seq Age Sex Outcome Treatment
    1