What are FDA adverse event reports for Interoperable Automated Glycemic Controller?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Interoperable Automated Glycemic Controller, there are 3,009 total reports including 3 death reports and 899 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Interoperable Automated Glycemic Controller?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Interoperable Automated Glycemic Controller

Name: Interoperable Automated Glycemic Controller - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1356 (Clinical Chemistry panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Interoperable Automated Glycemic Controller LIGHT-BOOK · MAUDE

#407 of 1000 · 3,009 reports · 2020–2026

BOOK 3,009 reports
RANK #407 of 1000
DEATH 3 death-typed
INJ 899 injury-typed
MALF 2,104 malfunction
SPAN 2020–2026
PEAK 2026: 2,959
PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Tracheal, Expandable (0 report gap)

Interoperable Automated Glycemic Controller sits #407 of 1000 among tracked device types with 3,009 MAUDE reports spanning 2020–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Interoperable Automated Glycemic Controller carries 69.9% MALFUNCTION-coded reports, 5.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 29.9% corpus 30.3% · near corpus mean (-0.4 pp)
MALF 69.9% corpus 64.8% · above corpus mean (+5.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 17% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 89% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Prosthesis

3,057
Interoperable… (this)

3,009
Prosthesis

3,009
Latex Patient…

2,992
Medical Devic…

2,981
System

2,966

What this shows Interoperable Automated Glycemic Controller carries 3,009 MAUDE reports, ranked #407 of 1000.

Event Types

Malfunction 2,104 (69.9%)

Injury 899 (29.9%)

Death 3 (0.1%)

Other 3 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,920 (67.5%)

Other 714 (25.1%)

Required Intervention 104 (3.7%)

H 37 (1.3%)

Hospitalization 30 (1.1%)

R 26 (0.9%)

Life Threatening 4 (0.1%)

O 3 (0.1%)

L 2 (0.1%)

Death 2 (0.1%)

Disability 1 (0.0%)

Yearly Trend

2020: 1

2021: 1

2022: 4

2023: 26

2024: 15

2025: 3

2026: 2,959

Reports fell to 3 in 2025, down from an average of 21 in the two years before.

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 2,642

Medtronic Puerto Rico Operations Co. 317

INSULET CORPORATION 15

TANDEM DIABETES CARE, INC. 8

BETA BIONICS, INC. 2

Event Locations

3,007 (99.9%)

NO INFORMATION 2 (0.1%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs Medtronic Puerto Rico Operations Co. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Interoperable Automated Glycemic Controller: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,009 here).

Prosthesis, Tracheal, Expandable 3,009 Latex Patient Examination Glove 2,992 Medical Device Data System 2,981 System, Photopheresis, Extracorporeal 2,966

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Interoperable Automated Glycemic Controller are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Interoperable Automated Glycemic Controller; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.

Interoperable Automated Glycemic Controller

Malfunction reports run above the device-type norm