URGENT FIELD SAFETY NOTIFICATION
Notification Letter
MiniMed™ 670G Insulin Pump (MMT-1780)
Potential Loss of Audio Issue
October 2018
Dear Valued Customer:
We have received reports of occurrences in which the MiniMed™ 670G 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 personal setting, or it could make no sound. Either of these occurrences could cause you
to miss system notifications, alarms or sirens associated with how the pump is working, and
with high and low glucose alerts. You are receiving this letter because our records indicate you
may have one of the potentially affected insulin pumps.
Explanation of Issue:
This issue occurs when a specific electronic component in your 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 your response 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 your pump, the audio cannot be
permanently repaired or regained. The only way to permanently regain your audio capabilities
is to exchange the affected pump with a replacement. Even if your 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 you have a pump that contains the specific
electronic component, and your pump passes the Audio Beep test described below, there is still
a chance that your pump may lose its audio capabilities at some future date.
What you should do:
1. If you have not already done so, enable the Vibrate feature on your pump. Even if the Audio
Beep test passes, you should enable the Vibrate feature (in addition to your Audio feature)
since it will add an additional notification to any alerts or alarms you may receive on your
pump.
Follow the steps below to enable both the Vibrate and Audio feature on your pump:
Press to open the Menu, Scroll down to Audio Options
Set Audio to “On”, Set Vibrate to “On” and Save
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