Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
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 Monitor For N… LIGHT-BOOK · MAUDE
#446 of 1000 · 2,582 reports · 2024–2026
- BOOK 2,582 reports
- RANK #446 of 1000
- DEATH 0 death-typed
- INJ 215 injury-typed
- MALF 2,361 malfunction
- SPAN 2024–2026
- PEAK 2025: 1,506
- PHOTO Iliac Covered Stent
Nearest event-volume peer: Iliac Covered Stent, Arterial (9 report gap)
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter sits #446 of 1000 among tracked device types with 2,582 MAUDE reports spanning 2024–2026. 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
Integrated Continuous Glucose Monitor For N… carries 91.4% MALFUNCTION-coded reports, 26.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 8.3% corpus 30.3% · below corpus mean (-22.0 pp)
- MALF 91.4% corpus 64.8% · above corpus mean (+26.6 pp)
Lead product-problem code Detachment of Device or Device Component is 58% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 95% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .
Integrated Continuous Glucose Monitor For N… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
2,621 reports
- Cerclage
Cerclage, Fixation
2,614 reports
- Catheter
Catheter, Conduction, Anesthetic
2,605 reports
- Catheter
Catheter, Urethral
2,601 reports
- Iliac Covered…
Iliac Covered Stent, Arterial
2,591 reports
- Integrated Co… (this)
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
2,582 reports
What this shows Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter carries 2,582 MAUDE reports, ranked #446 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
Related Entities for Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Integrated Continuous Glucose Monitor For N… carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,582 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Integrated Continuous Glucose Monitor For N… 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 Monitor For N…; 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.