Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the

FDA device recall Z-2442-2015 · posted 2015-08-21 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

Reason for recall

Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.

Action taken

A Urgent Medical Device recall letter was sent to customers on 7/22/15 to inform them that the Guardian Real-Time Continuous Glucose Monitoring System System has a language translation error that impacts the Finnish language. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact Nordic Support Line 0-800-164-064.

Root cause

Software design

Status

Terminated

Product code

MDS

Quantity affected

254 units

Distribution

Distributed in Finland.

Date initiated

2015-07-22

Date posted

2015-08-21

Date terminated

2015-09-18

Location

Northridge, CA