Medtronic, in consultation with the Therapeutic Goods Administration (TGA), has issued an Urgent Product Defect Correction letter for Medtronic MiniMed™ 640G Insulin Pumps with version 4.10 software.
Medtronic has confirmed reports of occurrences at a rate of between 0.14% and 0.3% where the MiniMed™ 640G insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms or sirens for system notifications and high/low glucose alerts.
Users are requested to perform an Audio Beep test to identify pumps that may be experiencing this potential issue. The steps for performing the test are provided in the customer letter sent by Medtronic.
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.
Medtronic has issued letters to customers that may be affected by this issue. A copy of the notification from Medtronic can be found here.
If customers have further questions or need assistance, please contact the Medtronic support line on 1800 777 808.