Field Safety Notice – Dana I pump (or Diabecare DANA-i) (Manufactured before October 2022)

We have been informed that there has been an increasing number of fractures in the battery securing parts of this pump. During the insulin pump use, if the device is dropped or excessive force is applied, some of the device's battery securing parts may break. This will result in the pump no longer functioning with risk of high glucose values and DKA.

Action to be taken by the user:

• When replacing the battery, avoid applying excessive force to the battery securing parts.
• Before use, carefully inspect and observe the battery securing parts for any signs of damage.
• If the battery securing parts are broken, immediately stop using the insulin pump and seek assistance from Advanced Therapeutics.  
• An improved version of the battery securing parts has been implemented since October 2022. Please confirm your DANA-i insulin pump's manufacturing date through the device's marking. The date of manufacture is indicated by the year and month after the date of manufacture symbol.
• Please contact Advanced therapeutics on 01926 426 028 with any concerns/ to apply for replacement improved version pumps.