BEUDAMED
    FDA Recall Terminated

    ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

    Recall: Z-0162-06 · Initiated April 27, 2005

    Recall

    Recall Number
    Z-0162-06
    Event Number
    33025
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 27, 2005
    Posted
    November 18, 2005
    Terminated
    March 20, 2007
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

    Reason

    The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.

    Action

    All end users who recieved the model MMT-515 or MMT-715 pump that included the 'Fine Yuning Your Pump' workbook will be notified through a letter.

    Distribution

    Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico.

    Quantity

    Approximately 14,560