BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN PUMP CARTRIDGE

    MDR report key: 1230126 · Received November 12, 2008

    Report

    Report Number
    MW5008977
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    August 3, 2006
    Report Date
    November 12, 2008
    Manufacturer
    SMITH MEDICAL MD, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CARTRIDGE FOR THE DELTEC COZMO/SMITHS MEDICAL MD, INC. INSULIN PUMP IS HAVING TROUBLE. THE PLUNGER WILL NOT SLIDE. SON HAD SOME HYPERGLYCEMIC EPISODES WHILE ON THE PUMP. WE CHANGED THE INSULIN, CARTRIDGE, AND INFUSION SET SEVERAL TIMES AND THE EPISODES CONTINUED. I CALLED THE HELP LINE AND AFTER DISCUSSION, THE CONSULTANT SUGGESTED THAT THE PROBLEM WAS THE CARTRIDGE. THE CARTRIDGE DOES NOT SLIDE DUE TO THE LACK OF LUBRICATION. EPISODE HAPPENED AGAIN APPROXIMATELY IN 2006. WE HAVE RECEIVED WARNINGS THAT WE NEED TO SLIDE THE PLUNGER UP AND DOWN SEVERAL TIMES BEFORE FILLING IT. THIS DOES NOT WORK. THE CARTRIDGE IS STILL GETTING STUCK. IN 2008 - WE CONTINUE TO HAVE THIS PROBLEM. WE HAVE TO OPEN AT LEAST 3 CARTRIDGES IN ORDER TO BE ABLE TO FILL ONE CARTRIDGE. THE OTHER 2 ARE GETTING STUCK - THE PLUNGER WILL NOT SLIDE. WE HAVE AN ENTIRE BAG OF CARTRIDGES THAT DON'T WORK. DATES OF USE: 2006 -- 2008. DIAGNOSIS OR REASON FOR USE: TYPE I DIABETES. EVENT ABATED AFTER USE STOPPED OR DOES REDUCED? NO. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN PUMP CARTRIDGE NONE LZG SMITH MEDICAL MD, INC. 045X68

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other