Events

Recall of Roche ACCUCHEK Spirit Plus insulin pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Disetronic Medical Systems, 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
    51695
  • Event Risk Class
    Class 2
  • Event Number
    Z-1646-2009
  • Event Initiated Date
    2009-04-30
  • Event Date Posted
    2009-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81008
  • 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
    Insulin Infusion Pump - Product Code LZG
  • Reason
    The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
  • Action
    The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification. On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees.

Device

Roche ACCUCHEK Spirit Plus insulin pump
  • Model / Serial
    All units with serial numbers SN02119552 thru SN10006093.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
  • Manufacturer
    Disetronic Medical Systems, Inc.

Manufacturer

Disetronic Medical Systems, Inc.
  • Manufacturer Address
    Disetronic Medical Systems, Inc., 11800 Exit 5 Pkwy Ste 120, Fishers IN 46037-7989
  • Source
    USFDA