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Saturday, November 22, 2014

URGENT Alert! Insulin Pump Malfunctions May Cause Death !

Urgent Health Advisory - Urgent Safety Information for Insulin Pump Users 

Health Canada just released this important safety advisory for people who use insulin pumps. A malfunction in the equipment may cause DEATH !  Please share widely!
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image  Omemee Pigeon Posted- Urgent Alert Insulin Pump Malfunction May Cause Death
Omemee Posted- Alert Notice - Insulin Pump Malfunction


  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.

Insulin Pump Problem

Patients 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.

Insulin Pump Malfunction Risk - Death

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.

Insulin Pump Users - Precautions

 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 on the Health Canada Website) to report the issue and receive instructions on how to return the affected infusion set to the company. 

Does this alert affect your family?
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