2026 data FDA MAUDE openFDA

Sensor, Glucose, Invasive, Non-Adjunctive

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, Glucose, Invasive, Non-Adjunctive HEAVY-BOOK · MAUDE

#12 of 1000 · 316,062 reports · 2016–2026

  • BOOK 316,062 reports
  • RANK #12 of 1000
  • DEATH 10 death-typed
  • INJ 2,301 injury-typed
  • MALF 313,751 malfunction
  • SPAN 2016–2026
  • PEAK 2018: 116,245
  • PHOTO Permanent Pacemaker E…

Nearest event-volume peer: Permanent Pacemaker Electrode (2,178 report gap)

Sensor, Glucose, Invasive, Non-Adjunctive sits #12 of 1000 among tracked device types with 316,062 MAUDE reports spanning 2016–2026. 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.7% corpus 30.4% · below corpus mean (-29.7 pp)
  • MALF 99.3% corpus 64.5% · above corpus mean (+34.8 pp)

Lead product-problem code Wireless Communication Problem is 47% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 75% of manufacturer-tagged reports · Top event location I is 76% of location-tagged rows .

Sensor, Glucose, Invasive, Non-Adjunctive in the event-volume neighbourhood

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

reports

What this shows Sensor, Glucose, Invasive, Non-Adjunctive carries 316,062 MAUDE reports, ranked #12 of 1000.

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

Event Types

Malfunction 313,751 (99.3%)
Injury 2,301 (0.7%)
Death 10 (0.0%)

Patient Outcomes

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

313,164 (99.1%)
Other 2,031 (0.6%)
Hospitalization 265 (0.1%)
Life Threatening 217 (0.1%)
O 191 (0.1%)
Required Intervention 77 (0.0%)
Disability 61 (0.0%)
H 34 (0.0%)
S 32 (0.0%)
Congenital Anomaly 30 (0.0%)
R 26 (0.0%)
Death 15 (0.0%)
D 1 (0.0%)

Top Product Problems

Wireless Communication Problem 160,816
Imprecision 51,355
Device Displays Incorrect Message 28,079
No Device Output 25,215
Use of Device Problem 24,263
Invalid Sensing 6,721
Premature End-of-Life Indicator 4,964
Communication or Transmission Problem 4,119
Unable to Obtain Readings 4,084
Defective Alarm 4,067
Display or Visual Feedback Problem 4,020
Device Inoperable 3,759
Inappropriate or Unexpected Reset 3,591
Detachment of Device or Device Component 2,966
Unexpected Shutdown 2,846
Incorrect, Inadequate or Imprecise Result or Readings 2,780
Battery Problem 2,328
Device Operates Differently Than Expected 2,209
Appropriate Term/Code Not Available 2,101
Low Battery 1,878

Yearly Trend

16
2016: 3
17
2017: 65,182
18
2018: 116,245
19
2019: 44,510
20
2020: 10,579
21
2021: 4,943
22
2022: 1,378
23
2023: 6,373
24
2024: 22,392
25
2025: 38,645
26
2026: 5,812

Related Entities for Sensor, Glucose, Invasive, Non-Adjunctive

Event Locations

I 240,235 (76.0%)
75,816 (24.0%)
NO INFORMATION 11 (0.0%)

Compare DEXCOM, INC. vs MEDTRONIC MINIMED →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Sensor, Glucose, Invasive, Non-Adjunctive, 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 (316,062 here).

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Disclaimer: MAUDE figures for Sensor, Glucose, Invasive, Non-Adjunctive 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, Glucose, Invasive, Non-Adjunctive; 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.