MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
- Company
- Medtronic Minimed Inc.
- Recall Initiated
- June 19, 2015
- Posted
- July 24, 2015
- Terminated
- October 2, 2015
- Recall Number
- Z-2260-2015
- Quantity
- 1936 units
- Firm Location
- Northridge, CA
Reason for Recall
Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
Distribution
Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.
Root Cause
Under Investigation by firm
Action Taken
A customern notification letter sent to customers on 6/19/15 who received the MiniMed 640G insulin pumps. The purpose of the letter is to inform customers that when using Bolus Wizard with the MiniMed 640G insulin pumps, that there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate. Customers are informed that Medtronic MiniMed has updated the user guide which instructs to respond promptly to set Bolus screens, and remind not to activate delivery on a bolus based on a blood glucose value that is more than 12 minutes old. The letter informs the customers of the summary of changes in the MiniMed 640G insulin pump user guides.