Safety Notice for MiniMed™ Mio™ Advance Infusion Sets – HPRA Safety Notice: SN202019(02). Priority 1 – For Immediate Action

The user guide currently recommends filling 6mm and 9mm soft cannulas with 0.9U (0.009 ml) of insulin after inserting a new set. Unomedical a/s has determined that the correct fill cannula volume is 0.6U for both 6mm and 9mm soft cannulas.

The MiniMed™ Mio™ Advance infusion set is used with all major insulin pump brands with luer-lock or MiniMed™ connections including Medtronic, Roche and Animas insulin infusion pumps. Only Medtronic MiniMed™ Mio™ Advance infusion sets are affected by this FSN.

Explanation of Issue: The current MiniMed™ Mio™ Advance infusion set user guide recommends that 6 mm and 9 mm soft cannulas be filled with 0.9 units (0.009 ml) of insulin after inserting a new set. The user guide is now being updated to recommend that 6 mm and 9 mm soft cannulas be filled with 0.6 units (0.006 ml) of insulin. Reducing the soft cannula insulin fill volume to 0.6 units (0.006 ml) will reduce the risk of potential hypoglycaemic events, particularly among paediatric patients.

In the interim period between now and when updated user guides are packaged with MiniMed™ Mio™ Advance infusion sets, patients will find a 1-page insert inside shipper boxes calling their attention to this matter. This is not a product recall and does not affect any other Medtronic MiniMed infusion set brands.

Please see detailed letter from Medtronic: SN201902_Medtronic_MiniMedMioAdvanced_PumpUserLetter_V38338

If you have any further questions or need assistance, please call the Medtronic Support Line at Tel No: 01 5111444.

This safety notice is also available on the HPRA website www.hpra.ie