BEUDAMED
    FDA Recall Terminated

    Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.

    Recall: Z-1105-05 · Initiated July 15, 2005

    Recall

    Recall Number
    Z-1105-05
    Event Number
    32659
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2005
    Posted
    August 6, 2005
    Terminated
    February 7, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.

    Reason

    The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.

    Action

    The firm began notifying family members of pediatric patients via phone on 7/15/05 and immediately began shipping a recall letter and 10 packs of replacement adapters to each pediatric user. Attending physicians were for these pediatric patients were notified the week of 7/18/05 via phone and follow-up letters were sent to these physicians. The firm is issuing a press release on 7/28/05. Only these replacement adapters are being sold by Disetronic to users of any age ordering new adapters.

    Distribution

    Nationwide.

    Quantity

    107 pediatric patients use the device.