2026 data FDA MAUDE openFDA FDA Class II

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

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 §862.1357 (Clinical Chemistry panel).

FDA MAUDE casebook

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

#386 of 1000 · 3,214 reports · 2024–2026

  • BOOK 3,214 reports
  • RANK #386 of 1000
  • DEATH 0 death-typed
  • INJ 716 injury-typed
  • MALF 2,496 malfunction
  • SPAN 2024–2026
  • PEAK 2026: 2,024
  • PHOTO System

Nearest event-volume peer: System, Dialysate Delivery, Sealed (0 report gap)

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate sits #386 of 1000 among tracked device types with 3,214 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 Monitoring Sy… carries 77.7% MALFUNCTION-coded reports, 12.8pp 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 22.3% corpus 30.3% · below corpus mean (-8.0 pp)
  • MALF 77.7% corpus 64.8% · above corpus mean (+12.8 pp)

Lead product-problem code Imprecision is 68% of coded problems · Lead manufacturer SENSEONICS INC. accounts for 93% of manufacturer-tagged reports · Top event location is 100% 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 With Sensor Containing Dexamethasone Acetate carries 3,214 MAUDE reports, ranked #386 of 1000.

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

Event Types

Malfunction 2,496 (77.7%)
Injury 716 (22.3%)
Other 2 (0.1%)

Patient Outcomes

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

2,552 (89.8%)
Hospitalization 214 (7.5%)
Other 71 (2.5%)
Death 2 (0.1%)
Congenital Anomaly 1 (0.0%)
Required Intervention 1 (0.0%)

Top Product Problems

Imprecision 2,252
Adverse Event Without Identified Device or Use Problem 434
Output Problem 236
Communication or Transmission Problem 125
Premature End-of-Life Indicator 75
Difficult to Remove 47
Unable to Obtain Readings 31
Connection Problem 22
Material Separation 18
Insufficient Device Problem Information 17
Failure to Sense 13
Battery Problem 8
Calibration Problem 8
Wireless Communication Problem 4
Installation-Related Problem 3
No Device Output 3
Overheating of Device 3
Device Sensing Problem 2
Environmental Compatibility Problem 2
Failure to Select Signal 2

Yearly Trend

24
2024: 17
25
2025: 1,173
26
2026: 2,024

Related Entities for Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Top Manufacturers

Event Locations

3,214 (100.0%)

Compare SENSEONICS INC. vs Senseonics Inc. →

Nationwide devices with a comparable report-volume footprint

Integrated Continuous Glucose Monitoring Sy… 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.

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.