Important Safety Alerts

Medical device manufacturer, Medtronic Limited, has issued a medical device safety alert concerning its MiniMed Silhouette and MiniMed Sure-T infusion sets.

As part of its global quality monitoring process, the manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets.

If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify the patient. The interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (DKA). DKA is a serious condition that can cause a severe impact to health, including death. Symptoms of DKA may include nausea, vomiting, shortness of breath and excess thirst/urination. Patients should seek medical attention immediately if they experience any of these symptoms.

According to the manufacturer, patients can continue to use their infusion sets by following the advice below:

• When changing the infusion set, patients should closely follow the instructions for use included in the product box. They should check the tubing at the site connector location identified in the drawings above to make sure it is not loose.
• As always, it is essential to monitor blood sugar levels frequently using a blood glucose meter. They should proactively check the tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring..
• If the patients experience a high blood sugar, they should check the tubing connections and infusion site closely to ensure tubing is secure.
• If the patients discover the tubing is detached, they should follow the instructions below:
  • Do not attempt to reattach the tubing. They should replace the infusion set immediately.
  • Treat any high blood sugar based on the guidelines provided.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 11 November 2014