2026 data FDA MAUDE openFDA FDA Class III

Sensor, Glucose, Implanted, Non-Adjunctive Use

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 Sensor LIGHT-BOOK · MAUDE

#454 of 1000 · 2,413 reports · 2020–2026

  • BOOK 2,413 reports
  • RANK #454 of 1000
  • DEATH 0 death-typed
  • INJ 1,226 injury-typed
  • MALF 1,187 malfunction
  • SPAN 2020–2026
  • PEAK 2024: 915
  • PHOTO Table

Nearest event-volume peer: Table, Operating-Room, Ac-Powered (7 report gap)

Sensor, Glucose, Implanted, Non-Adjunctive Use sits #454 of 1000 among tracked device types with 2,413 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 →

Injury-coded reports run above the device-type norm

Sensor carries 50.8% INJURY-coded reports, 20.5pp 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 50.8% corpus 30.3% · above corpus mean (+20.5 pp)
  • MALF 49.2% corpus 64.8% · below corpus mean (-15.6 pp)

Lead product-problem code Imprecision is 29% of coded problems · Lead manufacturer SENSEONICS INC. accounts for 97% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Sensor in the event-volume neighbourhood

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

reports

What this shows Sensor, Glucose, Implanted, Non-Adjunctive Use carries 2,413 MAUDE reports, ranked #454 of 1000.

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

Event Types

Injury 1,226 (50.8%)
Malfunction 1,187 (49.2%)

Patient Outcomes

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

1,520 (65.0%)
Other 680 (29.1%)
Hospitalization 139 (5.9%)
Death 1 (0.0%)

Top Product Problems

Imprecision 737
Failure to Sense 475
Adverse Event Without Identified Device or Use Problem 406
Difficult to Remove 286
Premature End-of-Life Indicator 256
Material Separation 95
Communication or Transmission Problem 55
Connection Problem 30
Output Problem 29
Device Sensing Problem 28
Installation-Related Problem 18
No Apparent Adverse Event 18
Optical Problem 16
Insufficient Device Problem Information 15
Battery Problem 9
Calibration Problem 9
Improper or Incorrect Procedure or Method 6
Chemical Problem 4
Device Ingredient or Reagent Problem 4
Environmental Compatibility Problem 4

Yearly Trend

20
2020: 18
21
2021: 9
22
2022: 173
23
2023: 341
24
2024: 915
25
2025: 635
26
2026: 322

Reports in 2025 (635) held close to the prior two-year average of 628.

Related Entities for Sensor, Glucose, Implanted, Non-Adjunctive Use

Event Locations

2,413 (100.0%)

Compare SENSEONICS INC. vs SENSEONICS INC →

Nationwide devices with a comparable report-volume footprint

Sensor 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 (2,413 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Sensor 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 Sensor; 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.