Medtronic Australasia Pty Ltd.
97 Waterloo Road North Ryde, NSW 2113
Phone: 1800 777 808

Safety Alert Information

URGENT: RECALL FOR PRODUCT CORRECTION

14 February 2017 MiniMedTM 640G Insulin Infusion Pump (ARTG 95763) Power Error 25 

(No product return is required)

Medtronic, in consultation with the Therapeutic Goods Adminstration (TGA) is initiating a Recall for Product Correction (TGA Reference number RC-2017-RN-00167-1) for its MiniMed 640G insulin pumps. Please note that physical product is not being recalled from the market.

Medtronic is committed to keeping you and your healthcare professional informed of potential issues and associated solutions related to our products and services. The purpose of this letter is to inform you of an issue potentially affecting your MiniMed 640G insulin pump.

Issue:

Medtronic has identified a software issue that could prevent the internal battery from charging in your pump. Should this software issue occur, an alarm is triggered and you will see the following ‘Power error detected’ message displayed on the pump screen:

If you experience this alarm and see the “Power error detected” message on your pump accompanied by the number “25”, please contact the Medtronic HelpLine team at 1800 777 808, option 1  for assistance with troubleshooting the error. 

Do not ignore this alarm and error message, which means that your pump has now stopped delivering insulin. If you do not take action, you could develop dangerously high blood sugar levels (hyperglycaemia).

The 24 Hour Helpline will troubleshoot to determine the cause of the Power Error 25 alarm and guide the user to perform a pump reset process which will reset the condition that causes the software anomaly to occur. If necessary the 24 Hour Helpline will offer to replace your insulin pump. 

Recommended actions to be taken:

  1. If you see a Power error 25 alarm, please contact the Medtronic Helpline at 1800 777 808, option 1.
  2. The Helpline will assist you in troubleshooting the alarm and determining the next steps, including the potential replacement of your pump.
  3. Please complete and return the attached acknowledgement form.
  4. Should you have any questions or concerns regarding this issue please do not hesitate to contact Medtronic HelpLine at 1800 777 808, option 1 or your healthcare professional.

 

Note: This issue only affects Version 2.6 of the MiniMed 640G Pump.  To check the version of your pump, please refer to the instructions below. 

Instructions to Check Pump Version

  1. Select the   button.
  2. Press up to highlight the icon bar 
  3. Select the   button.
  4. Highlight “Pump” and press the   button
  5. Scroll down until you see “Version”

Your safety and complete satisfaction are our first priority and we appreciate your time and attention to this important notification.


22nd July 2015  MiniMed® 640G – What ‘Recall for Product Correction’ actually means?

If you’re using the MiniMed® 640G System^, you may receive an alert when performing a bolus, related to either having dangerously low Blood Glucose, dangerously high BG or are trying to deliver a large bolus (as shown in the pictures). It is important that you clear these alerts immediately so that you can correctly deliver the bolus. It is also important to never use data older than 12 minutes to determine a bolus amount.

A new user guide will be sent to all users over the coming weeks.

Please contact us on 1800 777 808 if you have any questions.

                    

For more info, download the letter sent to MiniMed 640G users.

Read the letter here


23rd June 2015  Medtronic MiniMed® Sure-T® infusion sets Recall for Product Correction - potential for interuption of insulin delivery and/or infection due to needle breaking during use

Medtronic after consultation with the TGA (TGA Ref# RC-2015-RN-00506-1), is initiating a voluntary Recall for Product Correction for the above mentioned devices. As part of Medtronic’s product quality monitoring process, we identified that certain MiniMed® Sure-T® infusion sets* had a slight increase of reported cases where the steel needle broke during use. In a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. Since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks. 

For more info, download the letter.

Read the letter here