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
#37 of 1000 · 117,148 reports · 2017–2026
- BOOK 117,148 reports
- RANK #37 of 1000
- DEATH 13 death-typed
- INJ 17,413 injury-typed
- MALF 99,715 malfunction
- SPAN 2017–2026
- PEAK 2021: 69,065
- PHOTO Pump
Nearest event-volume peer: Pump, Infusion, Implanted, Programmable (349 report gap)
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated sits #37 of 1000 among tracked device types with 117,148 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 →
Malfunction reports run above the device-type norm
Sensor carries 85.1% MALFUNCTION-coded reports, 20.3pp 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 14.9% corpus 30.3% · below corpus mean (-15.4 pp)
- MALF 85.1% corpus 64.8% · above corpus mean (+20.3 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 97% of manufacturer-tagged reports · Top event location I is 65% of location-tagged rows .
Sensor in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Coronary Drug…
Coronary Drug-Eluting Stent
128,715 reports
- Device
Device, Hemostasis, Vascular
123,919 reports
- Electrosurgic…
Electrosurgical, Cutting & Coagulation & Accessories
117,697 reports
- Prosthesis
Prosthesis, Breast, Inflatable, Internal, Saline
117,618 reports
- Sensor (this)
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
117,148 reports
- Pump
Pump, Infusion, Implanted, Programmable
116,799 reports
What this shows Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated carries 117,148 MAUDE reports, ranked #37 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
Reports fell to 1,592 in 2025, down from an average of 7,771 in the two years before.
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 a comparable volume-and-death footprint
Two openFDA-derived peer sets for Sensor: 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 (117,148 here).
Similar death-typed counts
Nearest other device types by death-typed report count (13 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.