Events

Recall of Roche AccuCheck Spirit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diabetes Care, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71235
  • Event Risk Class
    Class 2
  • Event Number
    Z-1733-2015
  • Event Initiated Date
    2015-04-22
  • Event Date Posted
    2015-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136924
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, insulin - Product Code LZG
  • 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.

Device

Roche AccuCheck Spirit
  • Model / Serial
    All Serial Numbers  Models: 1. 05458544001, Accu-Chek Combo Kit mg US/English version. 2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4. 05391750001, Accu-Chek Spirit Combo Demo Pump  US. 5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6. 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7. 04759729001, Accu-Chek Spirit Replacement Pump.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AccuChek Spirit insulin infusion pump.
  • Manufacturer
    Roche Diabetes Care, Inc.

Manufacturer

Roche Diabetes Care, Inc.
  • Manufacturer Address
    Roche Diabetes Care, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA