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2026 data FDA MAUDE openFDA

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

#14 of 1000 · 280,884 reports · 1992–2026

  • BOOK 280,884 reports
  • RANK #14 of 1000
  • DEATH 320 death-typed
  • INJ 13,594 injury-typed
  • MALF 266,483 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 97,215
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Non-Continuous (Respirator) (15,806 report gap)

Sensor, Glucose, Invasive sits #14 of 1000 among tracked device types with 280,884 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.8% corpus 30.4% · below corpus mean (-25.6 pp)
  • MALF 94.9% corpus 64.5% · above corpus mean (+30.4 pp)

Lead product-problem code Wireless Communication Problem is 27% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 76% 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 280,884 MAUDE reports, ranked #14 of 1000.

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

Event Types

Malfunction 266,483 (94.9%)
Injury 13,594 (4.8%)
Other 419 (0.1%)
Death 320 (0.1%)
68 (0.0%)

Patient Outcomes

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

254,521 (90.3%)
Other 17,146 (6.1%)
Hospitalization 7,299 (2.6%)
Required Intervention 932 (0.3%)
O 720 (0.3%)
Death 395 (0.1%)
Life Threatening 292 (0.1%)
R 185 (0.1%)
Congenital Anomaly 143 (0.1%)
Disability 123 (0.0%)
H 102 (0.0%)
S 75 (0.0%)
L 60 (0.0%)
D 1 (0.0%)

Top Product Problems

Wireless Communication Problem 56,944
Device Displays Incorrect Message 42,857
Invalid Sensing 25,579
Device Operates Differently Than Expected 20,842
Use of Device Problem 15,091
No Audible Alarm 9,417
Communication or Transmission Problem 7,268
Imprecision 5,629
Defective Alarm 5,359
Battery Problem 3,985
Computer Software Problem 3,473
Inappropriate or Unexpected Reset 3,151
Device Inoperable 2,410
Adverse Event Without Identified Device or Use Problem 1,985
Display or Visual Feedback Problem 1,660
Break 1,498
Incorrect, Inadequate or Imprecise Result or Readings 1,236
Component Missing 1,220
Detachment Of Device Component 1,153
Appropriate Term/Code Not Available 1,035

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: 430

Related Entities for Sensor, Glucose, Invasive

Top Manufacturers

DEXCOM, INC. 211,916
MEDTRONIC MINIMED 38,390
DEXCOM INC. 14,782
ANIMAS CORPORATION 4,323
MEDTRONIC PUERTO RICO OPERATIONS MED-REL 3,545
LIFESCAN, INC. 2,108
MEDTRONIC PUERTO RICO OPERATIONS CO. 2,103
DEXCOM INC 1,682
DEXCOM, INC 772
ABBOTT DIABETES CARE INC. 242

Event Locations

I 177,015 (63.0%)
101,330 (36.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Sensor, Glucose, Invasive, 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 (280,884 here).

Ventilator, Non-Continuous 265,078 Automated External Defibrillators 263,821 Permanent Pacemaker Electrode 313,884 Sensor, Glucose, Invasive, Non-Adjunctive 316,062

Similar death-typed counts

Nearest other device types by death-typed report count (320 here), distinct from the volume row.

Set 307 Catheter 335 Temporary Non-Roller Type Right Heart Suppo… 336 Acid, Hyaluronic, Intraarticular 301

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.