Continuous Glucose Monitor Retrospective Data Analysis Software
Clinical Chemistry · 21 CFR 862.2120
Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Recent MDR events
2,060 adverse event reports on file
- Carelink Pro OnlineJul 27, 2026MalfunctionMedtronic Minimed2032227-2026-211770
- SOFTWARE, PRaaS VERSION 2.0AJul 27, 2026MalfunctionMedtronic Minimed2032227-2026-212733
- SOFTWARE, PRaaS VERSION 2.0AJul 27, 2026MalfunctionMedtronic Minimed2032227-2026-212844
- SOFTWARE, PRAAS VERSION 2.0AJul 16, 2026MalfunctionMedtronic Minimed2032227-2026-207696
- SOFTWARE, PRAAS VERSION 2.0AJul 15, 2026MalfunctionMedtronic Minimed2032227-2026-206352
- SOFTWARE, PRAAS VERSION 2.0AJul 15, 2026MalfunctionMedtronic Minimed2032227-2026-207176
- SOFTWARE, PRAAS VERSION 2.0AJul 14, 2026MalfunctionMedtronic Minimed2032227-2026-206004
- SOFTWARE, PRAAS VERSION 2.0AJul 14, 2026MalfunctionMedtronic Minimed2032227-2026-206218
- CARELINK PRO ONLINEJul 10, 2026MalfunctionMedtronic Minimed2032227-2026-204150
- CARELINK PRO ONLINEJul 9, 2026MalfunctionMedtronic Minimed2032227-2026-203482
Event type breakdown
Recalls
2 recall events for this product code
- Medtronic MiniMed, Inc.Open, ClassifiedNov 25, 2025
CareLink Clinic, REF: MMT-7350
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Z-0594-2026 · View FDA record ↗ - Medtronic Inc.TerminatedUnknown
CareLink iPro Version 1.10, Catalog No. MMT-7340
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Z-2898-2016 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Reliable Healthcare Logistics, Llc
Boca Raton, FL, US
Medtronic Minimed
NORTHRIDGE, CA, US
Glooko Inc
Palo Alto, CA, US
Insulet Corporation
Acton, MA, US
Dreamed Diabetes Ltd
Petah Tikva Tel Aviv, IL
Bigfoot Biomedical, Inc.
Milpitas, CA, US
Abbott Diabetes Care Inc.
ALAMEDA, CA, US
Welldoc
Columbia, MD, US
Teladoc Health, Inc. - Lewisville
Lewisville, TX, US
Senseonics, Inc.
Germantown, MD, US
Dexcom, Inc.
SAN DIEGO, CA, US
Tandem Diabetes Care, Inc.
San Diego, CA, US
Tidepool Project
Palo Alto, CA, US
Center Health Inc.
Hillsborough, CA, US
Onetwo Analytics Ab
Stockholm, SE
510(k) clearances
1 clearances for this product code