2025 data FDA MAUDE openFDA

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

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

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Integrated Continuous Glucose Monitoring Sy… LIGHT-BOOK · MAUDE

#799 of 1000 · 620 reports · 2018–2025

  • BOOK 620 reports
  • RANK #799 of 1000
  • DEATH 1 death-typed
  • INJ 18 injury-typed
  • MALF 601 malfunction
  • SPAN 2018–2025
  • PEAK 2024: 238
  • PHOTO Monitor

Nearest event-volume peer: Monitor, Apnea, Facility Use (0 report gap)

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management sits #799 of 1000 among tracked device types with 620 MAUDE reports spanning 2018–2025. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.9% corpus 30.4% · below corpus mean (-27.5 pp)
  • MALF 96.9% corpus 64.5% · above corpus mean (+32.4 pp)

Lead product-problem code Wireless Communication Problem is 63% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 99% of manufacturer-tagged reports · Top event location is 93% of location-tagged rows .

Integrated Continuous Glucose Monitoring Sy… in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management carries 620 MAUDE reports, ranked #799 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 601 (96.9%)
Injury 18 (2.9%)
Death 1 (0.2%)

Patient Outcomes

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

598 (94.8%)
Other 12 (1.9%)
R 4 (0.6%)
Life Threatening 4 (0.6%)
Required Intervention 4 (0.6%)
L 3 (0.5%)
O 2 (0.3%)
H 1 (0.2%)
S 1 (0.2%)
Death 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Wireless Communication Problem 385
Imprecision 83
No Device Output 40
Unable to Obtain Readings 27
Unexpected Shutdown 12
Appropriate Term/Code Not Available 9
Unintended Application Program Shut Down 8
No Audible Alarm 6
Operating System Version or Upgrade Problem 6
Defective Alarm 5
Detachment of Device or Device Component 4
Display or Visual Feedback Problem 4
Premature End-of-Life Indicator 4
Adverse Event Without Identified Device or Use Problem 3
Inappropriate or Unexpected Reset 3
Incorrect, Inadequate or Imprecise Result or Readings 3
Output Problem 2
Physical Resistance/Sticking 2
Product Quality Problem 2
Application Program Freezes, Becomes Nonfunctional 1

Yearly Trend

18
2018: 2
19
2019: 26
20
2020: 18
21
2021: 111
22
2022: 81
23
2023: 78
24
2024: 238
25
2025: 66

Related Entities for Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Event Locations

575 (92.7%)
I 31 (5.0%)
NO INFORMATION 14 (2.3%)

Compare DEXCOM, INC. vs DEXCOM INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Integrated Continuous Glucose Monitoring Sy…, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (620 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Integrated Continuous Glucose Monitoring Sy… 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 Integrated Continuous Glucose Monitoring Sy…; 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.