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Urgent safety information for insulin pump users
- Starting date:
- November 21, 2014
- Type of communication:
- Information Update
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Identification number:
- RA-42629
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 [NJS_FILE:446e83ae-308b-44b6-a893-4f5e772b68c5:c470c377-772e-4076-80c0-4c047cd6bb73], 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 |
|---|---|---|---|
| [NJS_FILE:446e83ae-308b-44b6-a893-4f5e772b68c5:1e1a74c4-5ba4-4b8b-8a93-107d86b003a6] | Paradigm Sure-T Infusion Sets |
MMT-862 MMT-864 MMT-874 |
1-800-646-4633 |
| Silhouette Infusion Sets |
MMT-371 MMT-373 |
||
| Paradigm Silhouette Infusion Sets |
MMT-377600 MMT-378600 MMT-381600 MMT-368600 MMT-383600 MMT-384600 |
||
| Roche Diagnostics | Accu-Chek Tender I |
04541430001 04541413001 04541448001 |
1-800-688-4578 |
| Accu-Chek Tender II |
04541464001 04541472001 |
||
| 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 |
10000600 10000601 10000602 10000603 |
1-877-937-7867 |
| Comfort Short Infusion Sets |
10024001 10024003 10024004 10024005 |
||
| Contact Detach Infusion Sets |
10090500 10090501 10090502 10090503 |
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
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Media Enquiries:
Health Canada
(613) 957-2983
Public Enquiries:
(613) 957-2991
1-866 225-0709