BEUDAMED
    FDA Recall Terminated

    AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

    Recall: Z-1733-2015 · Initiated April 22, 2015

    Recall

    Recall Number
    Z-1733-2015
    Event Number
    71235
    Firm
    Roche Diabetes Care, Inc.
    FEI Number
    3011393376
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 22, 2015
    Posted
    June 9, 2015
    Terminated
    November 3, 2016
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

    Reason

    Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u

    Action

    Roche sent an URGENT MEDICAL DEVICE CORRECTION notification dated April 22, 2015, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, customer responsibilities, training chart, and instructions for responding to the formal recall notification. Please contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-688-4578, if you have questions about the information contained in this notification.

    Distribution

    Nationwide Distribution

    Quantity

    35,795