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Source: Medicines & Healthcare products Regulatory Agency (MHRA)

Summary

The Slim X2 insulin pump, manufactured by Tandem Diabetes Care, has an exposed component that may cause and electrical shock to the user or patient.

Action

  • Identify patients supplied with affected insulin pumps
     
  • Ensure patients have received the manufacturer’s Field Safety Notice (FSN) with the replacement adapter. The adapters originally supplied with the pumps MUST be discarded
     
  • Acknowledge disposal of the adaptors by accessing the link referenced in the FSN, or by contacting the manufacturer directly
     
  • Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not
     

Action By

Healthcare professionals managing patients who use these devices

Deadlines for actions

Actions underway: 4th March 2020
Actions complete: 29th April 2020

Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.

Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for communication from MHRA.

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