BEUDAMED
    FDA Adverse Event Other Summary report: N

    COZMO DELTRONIC

    MDR report key: 939377 · Received November 5, 2007

    Report

    Report Number
    MW5004336
    Event Type
    Other
    Date Received
    November 5, 2007
    Date of Event
    September 1, 2007
    Report Date
    November 5, 2007
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITH MEDICAL IS MARKETING A NEW SERIES OF INSULIN PUMPS AS AN INTEGRATED PUMP AND BLOOD GLUCOSE METER AND THEY KNOW THAT THEIR SOFTWARE WHICH IS INCLUDED IS NOT COMPATABLE WITH THE NEW 1800 PUMP - WORKS GREAT WITH THE OLD 1700. PROMISED SOFTWARE FIXES HAVE BEEN MADE FOR SEVERAL MONTHS YET NOTHING COMES OF IT. I FEEL THIS IS GROSS NEGLIGENCE TO RELEASE THE PRODUCT BEFORE THE SOFTWARE TO USE, IT IS RELEASED! DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMO DELTRONIC NONE LZG 1800

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other