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Urgent - Medical device product defect correction

MiniMedTM 640G Insulin Pump (MMT-1711)

TGA Reference: RC-2018-RN-01321-1
ARTG: 95763

Medtronic have received reports of occurrences in which the MiniMedâ„¢ 640G insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms, or sirens. This failure could either cause the alarm volume to be stuck at a 4 (out of 5) level regardless of your patient's personal setting, or it could make no sound. Either of these occurrences could cause your patient to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. The purpose of this letter is to make you aware that we will be notifying all patients who may have one of the potentially affected insulin pumps. Patients will be emailed and/or sent a letter with information specific to the insulin pump model they are using.

The letter being sent to MiniMedTM 640G users will explain that they should enable the Vibrate feature and perform an Audio Beep test:

The Vibrate feature should be enabled on the pump and your patient should verify that it remains enabled with every set change. Even if the Audio Beep test passes, the Vibrate feature should be enabled (in addition to the Audio feature) since it will add an additional notification to any alerts or alarms received on the pump.

Follow the steps below to enable both the Vibrate and Audio feature on the insulin pump.

An Audio Beep test should be performed to see if the pump is experiencing this potential issue. This test will identify if the pump audio is working. The steps for this test can be found in the patient letter, and users can also access the website that will guide them through this process at https://pump.medtronic-diabetes.com.au/req-call-alert/

Important note: This test should be repeated with every set change and once mid-way through the infusion set use to verify the continued audio functionality of the pump.

If the pump fails the beep test, it will not permanently regain its audio capabilities and a replacement will be required to use the audio features of the pump. Even if the pump passes the Audio Beep test, patients should continue to perform regular beep tests to ensure continued audio functionality.

If you have concerns about monitoring your pump for this issue, we recommend to register at https://pump.medtronic-diabetes.com.au/req-call-alert/ and Medtronic Helpline will contact you within 5 business days to discuss potential options.

Problem/Issue Description: This issue occurs when a specific electronic component in the pump malfunctions; it can result in the loss of all audio, problems adjusting the audio volume, or the loss of only the emergency audio siren. This potential loss of audio could delay the patient's ability to respond to the underlying reason for the alert, alarm, or siren, which could then lead to possible health and safety risks such as hypoglycemia or hyperglycemia. If this issue occurs with the pump, the audio cannot be permanently repaired or regained. The only way to permanently regain audio capabilities is to exchange the affected pump with a replacement. Even if the pump has the audio issue, it will continue to deliver insulin as expected. Loss of the Vibrate feature has not been reported to occur as part of the above audio failure mode. If the pump contains the specific electronic component, and the pump passes the Audio Beep test described below, there is still a chance that the pump may lose its audio capabilities at some future date. The occurrence rate for this malfunction is between 0.14% and 0.3%. To address this issue, Medtronic Australia have updated the Diabetes Support Guides and Manuals webpage to include the Audio Beep Test Instructions which can be found here: https://www.medtronic-diabetes.com.au/support/guides-and-manuals

Additional Information

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local contact details

If you have further questions or need assistance, please call our support line at 1800 777 808

AUDIO BEEP TEST

Follow the steps listed below to determine if your pump is experiencing this issue. You may also use the following website to help you go through this process: https://pump.medtronic-diabetes.com.au/req-call-alert/

 
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