Urgent Product Correction and Removal on Disetronic Infusion Pumps
D-TRONplus Insulin Pump

Date: 2003-08-11

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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Disetronic Medical Systems, Inc. Contact the company for a copy of any references, attachments or enclosures.

Disetronic Medical Systems, Inc.
5151 Program Avenue
St. Paul, MN 55112-1014
800-280-7801
763-795-5200
Fax 763-795-5300
http://www.disetronic-usa.com

03-143
August 11, 2003
Canada

Dear Health Professional(s),

Introduction

Following an inspection of our infusion pump manufacturing facility, the U.S. Food and Drug Administration (FDA) determined that our manufacturing processes are not in substantial compliance with the regulations. In the absence of compliance with these regulations, the reliability of devices cannot be assured, which could potentially result in problems with the product leading to under and/or over infusion of insulin. Based on the evaluation of the observations with Health Canada, we have decided not to ship infusion pumps to any new customers until we have improved our manufacturing processes to adequately ensure the reliability of our pumps for their intended use. Some of the problems with the infusion pumps are listed in the individual pump letters that are enclosed with this letter. Disetronic is working closely with
Health Canada to resolve the situation.

This letter, together with copies of the Urgent Product Correction and Removal communications that have been sent to patients, is being sent to all physicians who have prescribed/recommended a Disetronic pump and to all Certified Disetronic Trainers.

Actions

• Please review the enclosed communications that have been sent to patients. It is our intent to provide you with as much information as possible so that you are fully informed and able to discuss this issue with your patients if/when questions arise.
• While we will continue to support pumps to existing customers, we ask that you DO NOT prescribe a Disetronic pump to any new patients at this time. We will notify you when you can resume prescribing pumps with the reliability that your patients deserve.
• We have also included answers to frequently asked questions on our website
  ( http://www.disetronic-usa.com).

Questions

Disetronic deeply regrets any inconvenience this situation may cause, and is committed to supporting our existing customers by providing disposable pump supplies, as well as ongoing support. Please call 1-866-307-2344 if you have questions about the information contained in this letter or concerns about your patients using a Disetronic infusion pump.

Any suspected adverse incident can also be reported to:
&Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
OTTAWA, Ontario, K1A 0K9
Tel: The Medical Devices Hotline 1-800-267-9675