2 May 2017
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion. – click on this headline to see the full notice.
- Identify all users of Accu-Chek Insight insulin pumps.
- Ensure that all patients and carers:
- Receive the manufacturer’s Field Safety Notice (FSN)
- understand the problem detailed in the FSN and follow the advice given by the manufacturer
- use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer and follow the steps described in the handling instructions in the FSN
- Contact Roche if you experience unexpected pump shut down or rapid battery depletion.
- Return the FSN acknowledgment form to Roche as currently the manufacturer hasn’t received enough responses.