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 Class II (moderate risk, special controls required), regulated under 21 CFR §862.1355 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Integrated Continuous Glucose Monitoring Sy… LIGHT-BOOK · MAUDE
#817 of 1000 · 620 reports · 2018–2025
- BOOK 620 reports
- RANK #817 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 #817 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 →
Malfunction reports run above the device-type norm
Integrated Continuous Glucose Monitoring Sy… carries 96.9% MALFUNCTION-coded reports, 32.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 2.9% corpus 30.3% · below corpus mean (-27.4 pp)
- MALF 96.9% corpus 64.8% · above corpus mean (+32.1 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
- Nebulizer
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
623 reports
- Cable
Cable, Transducer And Electrode, Patient, (Including Connector)
622 reports
- Gram-Positive…
Gram-Positive Bacteria And Their Resistance Markers
621 reports
- Integrated Co… (this)
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
620 reports
- Monitor
Monitor, Apnea, Facility Use
620 reports
- Container
Container, Empty, For Collection & Processing Of Blood & Blood Components
615 reports
What this shows Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management carries 620 MAUDE reports, ranked #817 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 238 in 2024, up from an average of 80 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Integrated Continuous Glucose Monitoring Sy…: 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 (620 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.