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2026 data FDA MAUDE openFDA FDA Class III

Sensor, Glucose, Invasive

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.

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FDA MAUDE casebook

openFDA event book Sensor, Glucose, Invasive HEAVY-BOOK · MAUDE

#16 of 1000 · 281,941 reports · 1992–2026

  • BOOK 281,941 reports
  • RANK #16 of 1000
  • DEATH 321 death-typed
  • INJ 13,632 injury-typed
  • MALF 267,501 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 97,215
  • PHOTO Automated External De…

Nearest event-volume peer: Automated External Defibrillators (Non-Wearable) (13,244 report gap)

Sensor, Glucose, Invasive sits #16 of 1000 among tracked device types with 281,941 MAUDE reports spanning 1992–2026. 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

Sensor, Glucose, Invasive carries 94.9% MALFUNCTION-coded reports, 30.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.8% corpus 30.3% · below corpus mean (-25.5 pp)
  • MALF 94.9% corpus 64.8% · above corpus mean (+30.1 pp)

Lead product-problem code Device Operates Differently Than Expected is 26% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 75% of manufacturer-tagged reports · Top event location I is 63% of location-tagged rows .

Sensor, Glucose, Invasive in the event-volume neighbourhood

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

reports

What this shows Sensor, Glucose, Invasive carries 281,941 MAUDE reports, ranked #16 of 1000.

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

Event Types

Malfunction 267,501 (94.9%)
Injury 13,632 (4.8%)
Other 419 (0.1%)
Death 321 (0.1%)
68 (0.0%)

Patient Outcomes

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

255,361 (90.3%)
Other 17,168 (6.1%)
Hospitalization 7,304 (2.6%)
Required Intervention 943 (0.3%)
O 720 (0.3%)
Death 395 (0.1%)
Life Threatening 292 (0.1%)
R 191 (0.1%)
Congenital Anomaly 143 (0.1%)
Disability 124 (0.0%)
H 103 (0.0%)
S 75 (0.0%)
L 61 (0.0%)
D 2 (0.0%)

Top Product Problems

Device Operates Differently Than Expected 81,012
Wireless Communication Problem 60,071
Device Displays Incorrect Message 57,574
Use of Device Problem 25,692
Invalid Sensing 25,600
No Audible Alarm 12,119
Communication or Transmission Problem 7,506
Defective Alarm 7,033
Imprecision 5,653
Adverse Event Without Identified Device or Use Problem 4,267
Battery Problem 4,178
Computer Software Problem 3,501
Inappropriate or Unexpected Reset 3,166
Device Inoperable 3,122
Component Missing 2,983
Detachment Of Device Component 2,967
Break 2,354
Insufficient Device Problem Information 2,273
Display or Visual Feedback Problem 1,799
Incorrect, Inadequate or Imprecise Result or Readings 1,606

Yearly Trend

92
1992: 1
04
2004: 1
06
2006: 1
07
2007: 14
08
2008: 20
09
2009: 127
10
2010: 4,957
11
2011: 6,450
12
2012: 1,821
13
2013: 683
14
2014: 36,209
15
2015: 39,944
16
2016: 97,215
17
2017: 48,848
18
2018: 9,085
19
2019: 2,127
20
2020: 935
21
2021: 590
22
2022: 10,571
23
2023: 13,882
24
2024: 4,138
25
2025: 2,835
26
2026: 1,487

Reports fell to 2,835 in 2025, down from an average of 9,010 in the two years before.

Related Entities for Sensor, Glucose, Invasive

Top Manufacturers

DEXCOM, INC. 211,917
MEDTRONIC MINIMED 39,434
DEXCOM INC. 14,782
ANIMAS CORPORATION 4,323
MEDTRONIC PUERTO RICO OPERATIONS MED-REL 3,545
MEDTRONIC PUERTO RICO OPERATIONS CO. 2,115
LIFESCAN, INC. 2,108
DEXCOM INC 1,682
DEXCOM, INC 772
ABBOTT DIABETES CARE INC. 242

Event Locations

I 177,015 (62.8%)
102,387 (36.3%)
HOME 1,318 (0.5%)
NO INFORMATION 820 (0.3%)
OTHER 334 (0.1%)
HOSPITAL 48 (0.0%)
OUTPATIENT TREATMENT FACILITY 11 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
NURSING HOME 3 (0.0%)

Compare DEXCOM, INC. vs MEDTRONIC MINIMED →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sensor, Glucose, Invasive: 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 (281,941 here).

Automated External Defibrillators 268,697 Ventilator, Non-Continuous 300,898 Set, Administration, Intravascular 309,977 Sensor, Glucose, Invasive, Non-Adjunctive 324,715

Similar death-typed counts

Nearest other device types by death-typed report count (321 here), distinct from the volume row.

Alternate Controller Enabled Insulin Infusi… 319 Acid, Hyaluronic, Intraarticular 307 Catheter 307 Set 307

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Sensor, Glucose, Invasive 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; 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.