Urgent safety information for insulin pump users
- Starting date:
- November 21, 2014
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Identification number:
November 21, 2014
For immediate release
OTTAWA – Unomedical a/s, in consultation with Health Canada, is informing Canadians and Canadian healthcare practitioners that there is a potential safety issue regarding infusion sets distributed by Medtronic of Canada Inc., Roche Diagnostics, LifeScan Canada Inc., and Auto Control Medical Inc.
Unomedical a/s, the manufacturer of these infusion sets, has identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the products. Patients who are concerned about their device should contact their distributor.
If tubing detachment occurs, insulin delivery is interrupted and the pump alarm will not notify the user, according to the manufacturer. The risk to patients of an interruption in insulin delivery is hyperglycemia (elevated blood sugar levels). Hyperglycemia can result in diabetic ketoacidosis, which is a serious condition, and in extreme cases can lead to death. Symptoms of diabetic ketoacidosis may include nausea, vomiting, shortness of breath and excess thirst/urination.
The manufacturer is advising patients to continue to use the infusion sets while following the directions below:
- When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the site connector location to make sure it is not loose.
- Monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
- If you experience high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover that the tubing is detached:
- Do not attempt to reattach the tubing. Replace the infusion set immediately.
- Treat any high blood sugar based on guidelines provided by your healthcare professional.
- Call your distributor (see table below) to report the issue and receive instructions on how to return the affected infusion set to the company.
|Company||Model||Reference Number||Contact Information|
|Medtronic of Canada Ltd.||Paradigm Sure-T Infusion Sets||
|Silhouette Infusion Sets||
|Paradigm Silhouette Infusion Sets||
|Roche Diagnostics||Accu-Chek Tender I||
|Accu-Chek Tender II||
|Auto Control Medical Inc.||Comfort Short Infusion Sets||89-060-2522||
(905) 814-6350 x 252
1-800-461-0991 x 252
|LifeScan Canada Ltd||Comfort Kit Infusion Sets||
|Comfort Short Infusion Sets||
|Contact Detach Infusion Sets||
Health Canada would also like to remind patients who have health concerns related to their use of these devices to speak with their healthcare professional.
Complaints about medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
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