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

Safety Alert Information

URGENT MEDICAL DEVICE RECALL FOR PRODUCT CORRECTION

June 2017 MiniMed® 640G Insulin Infusion Pump (ARTG 95763) Temporary Unresponsive Keypad

(Physical Return of Product is Not Required)

Dear Valued Customer:

Medtronic, in consultation with the Therapeutic Goods Administration (TGA), is initiating a Recall for Product Correction (TGA Reference Number RC-2017-RN-00661-1) for its MiniMed® 640G insulin pumps. Please note, pumps are 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 a rare and temporary condition potentially affecting your MiniMed® 640G insulin pump.

Issue:

Medtronic has identified thatthe keypad buttons on your MiniMed® 640G insulin pump may become temporarily stuck and unresponsive. You do not need to return or replace your pump. We do ask that you read the important information below to help you understand when this situation might happen, and how to resolve it.

How does the keypad become temporarily unresponsive?

Keypad buttons on the MiniMed® 640G insulin pump may become temporarily unresponsive when the atmospheric pressure around the pump increases or decreases rapidly. This would most likely happen when traveling in an airplane during take-off or landing. If this happens, in most cases you may not even notice because the pump will resolve this on its own.

How will I notice if this happens to my pump?

During this temporary situation, a button may be too difficult to press down or a button can look like it is pressed and stuck in that position.

  • If you notice the keypad buttons are difficult to press down, the pump will continue to deliver your basal insulin. You may not be able to program a bolus or suspend delivery as the buttons temporarily will not press down, but this will resolve on its own, usually within 30 minutes.
  • If a button is stuck in a pressed position, after three (3) minutes a “Stuck Button” alarm is triggered which suspends insulin delivery (including basal insulin). You may not be able to clear the alarm as the keypad is unresponsive. In the rare situation where this continues for more than ten (10) minutes, the pump will begin to siren.

Once the alarm is triggered and insulin is suspended, you will be unable to program a bolus or resume insulin delivery until the alarm is cleared.

The above could theoretically result in hypo or hyper glycaemia – close monitoring is advised and use of emergency kit insulin or disconnection of device may be required.

What should I do if this happens to my pump?

If you experience this temporary keypad condition, and want to resolve it immediately to bolus or clear the alarm, remove the battery cap from the pump and then place it back on.

PLEASE NOTE: You should have a fresh new AA battery available in case your pump prompts you to insert a new battery.

What if I have more questions?

If you have other questions or concerns, you can find an FAQ and a copy of this letter at https://www.medtronic-diabetes.com.au/customer-support/safety-information You can also always reach the Medtronic 24-Hour Helpline at 1800-777-808.

Note: This only applies to the MiniMed® 640G insulin pump. The MiniMed® Paradigm insulin pumps are not affected by this condition.

Medtronic considers patient safety and customer satisfaction our primary priorities. We appreciate your time and attention in reading this important notification.

Sincerely,

Michele Blanshard
Business Director, ANZ
Medtronic Diabetes Australia

 

Frequently Asked Questions

Q. IS THIS A RECALL?

Medtronic, in consultation with the Therapeutic Goods Administration (TGA) is initiating a Recall for Product Correction. Please note, no actual product return is required and the pumps are not being physically recalled from the market.

Q. DOES MY PUMP REQUIRE REPLACEMENT IF THIS HAPPENS?

No, you do not have to replace your pump unless the action of removing and replacing the battery cap does not resolve the problem. If this does not relieve the pressure and the keypad does not function as normal, please call your local HelpLine to trouble shoot and find out what next steps should be taken.

Q. WHAT CAN I DO TO RESOLVE THIS SITUATION IF IT HAPPENS TO MY PUMP?

The easiest thing to do if you are not experiencing a “Stuck Button” alarm is to wait for the pump to resolve the issue on its own. However, we acknowledge that you may want to resolve this issue quickly, therefore the solution is to remove the battery cap and put it back on the pump

Q. IS THERE SOMETHING I CAN DO WHILE FLYING TO AVOID THIS SITUATION FROM HAPPENING?

This is a very rare and temporary condition. However, if you wish to avoid this completely while in flight, you should temporarily remove the battery cap during take-off and landing and only place it back on after your flight has leveled in altitude. Remember: It is recommended to have extra new batteries and a backup therapy particularly when you travel in the unlikely event that your pump is unavailable.

Q. HOW COMMON IS THIS PROBLEM AND WHAT ARE MY CHANCES OF THIS HAPPENING WHEN TRAVELING IN AN AIRPLANE?

This is a rare situation and we do not expect this to happen in most cases. However, because of the potential therapy interruption and simple solution, we have chosen to make our patients aware of this condition. Remember: It is recommended to have extra new batteries and a backup therapy particularly when you travel in the unlikely event that your pump is unavailable.

Q. ARE THERE ANY PRECAUTIONS I CAN TAKE NOW TO HELP PREVENT THIS?

The best action for ensuring therapy is not or is minimally interrupted for this situation is to: a) Always carry a fresh new AA battery for the pump b) Always carry an HCP-prescribed back up therapy in the unlikely event the pump is not available

Q. WILL MY PUMP STOP DELIVERING INSULIN IF THIS ISSUE OCCURS?

Your pump will only stop delivering insulin if a button is stuck in a pressed position forthree (3) minutes and a “Stuck Button” alarm is triggered which suspends insulin. In the case where the keypad buttons are difficult to press down, your insulin delivery will not be interrupted.

Q. DOES THIS AFFECT THE PRESSURE IN THE RESERVOIR COMPARTMENT, AS WELL?

No, the p-cap feature on the reservoir allows the insulin reservoir compartment to equalise presser faster than the rest of the body of the pump. Therefore, the delivery of insulin will continue as usual unless the pump keypad is stuck and alarming.

Q. WHAT DO I DO IF THIS DOES NOT FIX THE PROBLEM?

If removing and replacing the battery cap does not resolve keypad responsiveness, please call your local HelpLine on 1800-777-808.


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