Integrated Continuous Glucose Monitoring System, Factory Calibrated
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 Integrated Continuous Glucose Monitoring Sy… HEAVY-BOOK · MAUDE
#2 of 1000 · 1,913,309 reports · 2018–2026
- BOOK 1,913,309 reports
- RANK #2 of 1000
- DEATH 174 death-typed
- INJ 31,666 injury-typed
- MALF 1,881,432 malfunction
- SPAN 2018–2026
- PEAK 2025: 379,883
- PHOTO Pump, Infusion
Nearest event-volume peer: Pump, Infusion (109,693 report gap)
Integrated Continuous Glucose Monitoring System, Factory Calibrated sits #2 of 1000 among tracked device types with 1,913,309 MAUDE reports spanning 2018–2026. 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 1.7% corpus 30.4% · below corpus mean (-28.8 pp)
- MALF 98.3% corpus 64.5% · above corpus mean (+33.8 pp)
Lead product-problem code Wireless Communication Problem is 40% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 98% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .
Integrated Continuous Glucose Monitoring Sy… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Integrated Co… (this)
Integrated Continuous Glucose Monitoring System, Factory Calibrated
1,913,309 reports
- Pump, Infusion
Pump, Infusion
1,803,616 reports
- Alternate Con…
Alternate Controller Enabled Insulin Infusion Pump
1,088,188 reports
- Pump
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
886,701 reports
- Automated Ins…
Automated Insulin Dosing Device System, Single Hormonal Control
838,920 reports
- Pump 534,449
Pump, Infusion, Insulin
534,449 reports
What this shows Integrated Continuous Glucose Monitoring System, Factory Calibrated carries 1,913,309 MAUDE reports, ranked #2 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 Integrated Continuous Glucose Monitoring System, Factory Calibrated
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Integrated Continuous Glucose Monitoring Sy…, 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 (1,913,309 here).
Similar death-typed counts
Nearest other device types by death-typed report count (174 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Integrated Continuous Glucose Monitoring Sy… 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 Integrated Continuous Glucose Monitoring Sy…; 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.