Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
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 HEAVY-BOOK · MAUDE
#35 of 1000 · 114,527 reports · 2017–2026
- BOOK 114,527 reports
- RANK #35 of 1000
- DEATH 12 death-typed
- INJ 17,161 injury-typed
- MALF 97,347 malfunction
- SPAN 2017–2026
- PEAK 2021: 69,065
- PHOTO Electrosurgical
Nearest event-volume peer: Electrosurgical, Cutting & Coagulation & Accessories (10 report gap)
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated sits #35 of 1000 among tracked device types with 114,527 MAUDE reports spanning 2017–2026. 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 15.0% corpus 30.4% · below corpus mean (-15.5 pp)
- MALF 85.0% corpus 64.5% · above corpus mean (+20.5 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 80% of coded problems · Lead manufacturer ABBOTT DIABETES CARE INC accounts for 98% of manufacturer-tagged reports · Top event location I is 67% of location-tagged rows .
Sensor in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Device
Device, Hemostasis, Vascular
121,291 reports
- System
System, Surgical, Computer Controlled Instrument
118,454 reports
- Sensor (this)
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
114,527 reports
- Electrosurgic…
Electrosurgical, Cutting & Coagulation & Accessories
114,517 reports
- Pump
Pump, Infusion, Implanted, Programmable
114,088 reports
- Prosthesis
Prosthesis, Breast, Inflatable, Internal, Saline
113,497 reports
What this shows Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated carries 114,527 MAUDE reports, ranked #35 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Related Entities for Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Top Manufacturers
Event Locations
Compare ABBOTT DIABETES CARE INC vs ABBOTT DIABETES CARE INC. →
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 (114,527 here).
Similar death-typed counts
Nearest other device types by death-typed report count (12 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.