2026 data FDA MAUDE openFDA

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

#655 of 1000 · 1,005 reports · 2025–2026

  • BOOK 1,005 reports
  • RANK #655 of 1000
  • DEATH 0 death-typed
  • INJ 31 injury-typed
  • MALF 974 malfunction
  • SPAN 2025–2026
  • PEAK 2026: 863
  • PHOTO Stabilizer, Heart

Nearest event-volume peer: Stabilizer, Heart (6 report gap)

Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System sits #655 of 1000 among tracked device types with 1,005 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 →

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 3.1% corpus 30.4% · below corpus mean (-27.4 pp)
  • MALF 96.9% corpus 64.5% · above corpus mean (+32.4 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 1,005 MAUDE reports, ranked #655 of 1000.

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

Event Types

Malfunction 974 (96.9%)
Injury 31 (3.1%)

Patient Outcomes

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

953 (96.6%)
Other 30 (3.0%)
Required Intervention 4 (0.4%)

Top Product Problems

Wireless Communication Problem 656
Incorrect, Inadequate or Imprecise Result or Readings 311
Calibration Problem 103
Retraction Problem 37
Unexpected Therapeutic Results 31
Activation Problem 12
Break 10
Delivered as Unsterile Product 6
Loss of or Failure to Bond 6
Material Twisted/Bent 5
Activation, Positioning or Separation Problem 3
Firing Problem 2
Material Integrity Problem 2
Physical Resistance/Sticking 2
Product Quality Problem 2
Adverse Event Without Identified Device or Use Problem 1
Device Difficult to Program or Calibrate 1
Difficult to Remove 1
Failure to Fire 1
Manufacturing, Packaging or Shipping Problem 1

Yearly Trend

25
2025: 142
26
2026: 863

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

Event Locations

1,005 (100.0%)

Compare MEDTRONIC MINIMED vs MEDTRONIC PUERTO RICO OPERATIONS CO. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Sensor, 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 (1,005 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.