2026 data FDA MAUDE openFDA FDA Class III

Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

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

#368 of 1000 · 3,653 reports · 2025–2026

  • BOOK 3,653 reports
  • RANK #368 of 1000
  • DEATH 0 death-typed
  • INJ 72 injury-typed
  • MALF 3,581 malfunction
  • SPAN 2025–2026
  • PEAK 2026: 3,511
  • PHOTO Tissue Adhesive For T…

Nearest event-volume peer: Tissue Adhesive For The Topical Approximation Of Skin (22 report gap)

Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System sits #368 of 1000 among tracked device types with 3,653 MAUDE reports spanning 2025–2026. 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 carries 98.0% MALFUNCTION-coded reports, 33.2pp 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 2.0% corpus 30.3% · below corpus mean (-28.3 pp)
  • MALF 98.0% corpus 64.8% · above corpus mean (+33.2 pp)

Lead product-problem code Wireless Communication Problem is 55% of coded problems · Lead manufacturer MEDTRONIC MINIMED 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, Invasive, Component Of Automated Insulin Delivery System carries 3,653 MAUDE reports, ranked #368 of 1000.

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

Event Types

Malfunction 3,581 (98.0%)
Injury 72 (2.0%)

Patient Outcomes

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

3,508 (97.9%)
Other 62 (1.7%)
Required Intervention 9 (0.3%)
H 2 (0.1%)
O 1 (0.0%)
R 1 (0.0%)
Hospitalization 1 (0.0%)

Top Product Problems

Wireless Communication Problem 2,358
Incorrect, Inadequate or Imprecise Result or Readings 1,123
Calibration Problem 328
Retraction Problem 142
Activation Problem 66
Unexpected Therapeutic Results 53
Break 48
Delivered as Unsterile Product 31
Material Twisted/Bent 23
Loss of or Failure to Bond 20
Material Integrity Problem 13
Packaging Problem 12
Failure to Calibrate 10
Failure to Sense 10
Output below Specifications 10
Manufacturing, Packaging or Shipping Problem 9
Activation, Positioning or Separation Problem 6
Difficult to Remove 6
Adverse Event Without Identified Device or Use Problem 5
Failure to Fire 4

Yearly Trend

25
2025: 142
26
2026: 3,511

Related Entities for Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

Event Locations

3,653 (100.0%)

Compare MEDTRONIC MINIMED vs MEDTRONIC PUERTO RICO OPERATIONS CO. →

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 (3,653 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.