Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
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 Class II (moderate risk, special controls required), regulated under 21 CFR §862.1355 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Integrated Continuous Glucose Monitoring Sy… HEAVY-BOOK · MAUDE
#24 of 1000 · 165,468 reports · 2020–2026
- BOOK 165,468 reports
- RANK #24 of 1000
- DEATH 29 death-typed
- INJ 41,805 injury-typed
- MALF 123,626 malfunction
- SPAN 2020–2026
- PEAK 2023: 39,322
- PHOTO System
Nearest event-volume peer: System, Peritoneal, Automatic Delivery (968 report gap)
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems sits #24 of 1000 among tracked device types with 165,468 MAUDE reports spanning 2020–2026. 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
Integrated Continuous Glucose Monitoring Sy… carries 74.7% MALFUNCTION-coded reports, 9.9pp 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 25.3% corpus 30.3% · below corpus mean (-5.0 pp)
- MALF 74.7% corpus 64.8% · above corpus mean (+9.9 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 65% of coded problems · Lead manufacturer ABBOTT DIABETES CARE INC accounts for 85% of manufacturer-tagged reports · Top event location is 89% 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
- Mesh
Mesh, Surgical, Polymeric
170,120 reports
- Staple
Staple, Implantable
169,612 reports
- Defibrillator
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
169,573 reports
- Integrated Co… (this)
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
165,468 reports
- System
System, Peritoneal, Automatic Delivery
164,500 reports
- Prosthesis
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
157,471 reports
What this shows Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems carries 165,468 MAUDE reports, ranked #24 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 20,527 in 2025, down from an average of 37,217 in the two years before.
Related Entities for Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Top Manufacturers
Event Locations
Compare ABBOTT DIABETES CARE INC vs ABBOTT DIABETES CARE LTD →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Integrated Continuous Glucose Monitoring Sy…: 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 (165,468 here).
Similar death-typed counts
Nearest other device types by death-typed report count (29 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.