Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.

FDA Recall Z-2442-2015 · Posted 2015-08-21

Recalling FirmMedtronic MiniMed Inc.
Recall StatusTerminated
Product CodeMDS
Date Initiated2015-07-22
Date Terminated2015-09-18
Product Quantity254 units

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.

Firm Action

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

Distribution Pattern

Distributed in Finland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑