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),

FDA device recall Z-2260-2015 · posted 2015-07-24 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FRN

Quantity affected

1936 units

Distribution

Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.

Date initiated

2015-06-19

Date posted

2015-07-24

Date terminated

2015-10-02

Location

Northridge, CA