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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §862.1355 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Integrated Continuous Glucose Monitoring Sy… HEAVY-BOOK · MAUDE

#2 of 1000 · 2,174,195 reports · 2007–2026

  • BOOK 2,174,195 reports
  • RANK #2 of 1000
  • DEATH 226 death-typed
  • INJ 40,360 injury-typed
  • MALF 2,133,519 malfunction
  • SPAN 2007–2026
  • PEAK 2025: 379,890
  • PHOTO Pump, Infusion

Nearest event-volume peer: Pump, Infusion (347,186 report gap)

Integrated Continuous Glucose Monitoring System, Factory Calibrated sits #2 of 1000 among tracked device types with 2,174,195 MAUDE reports spanning 2007–2026. 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 98.1% MALFUNCTION-coded reports, 33.3pp 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 1.9% corpus 30.3% · below corpus mean (-28.4 pp)
  • MALF 98.1% corpus 64.8% · above corpus mean (+33.3 pp)

Lead product-problem code Wireless Communication Problem is 37% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 91% of manufacturer-tagged reports · Top event location is 76% 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

reports

What this shows Integrated Continuous Glucose Monitoring System, Factory Calibrated carries 2,174,195 MAUDE reports, ranked #2 of 1000.

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

Event Types

Malfunction 2,133,519 (98.1%)
Injury 40,360 (1.9%)
Death 226 (0.0%)
Other 88 (0.0%)
2 (0.0%)

Patient Outcomes

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

2,117,116 (97.7%)
Other 22,988 (1.1%)
Required Intervention 14,191 (0.7%)
Hospitalization 3,605 (0.2%)
O 3,377 (0.2%)
H 3,253 (0.2%)
Life Threatening 921 (0.0%)
R 878 (0.0%)
S 483 (0.0%)
L 435 (0.0%)
Disability 356 (0.0%)
Death 158 (0.0%)
D 58 (0.0%)
Congenital Anomaly 3 (0.0%)
C 1 (0.0%)

Top Product Problems

Wireless Communication Problem 796,288
No Device Output 298,077
Incorrect, Inadequate or Imprecise Result or Readings 179,338
Low Readings 154,088
Detachment of Device or Device Component 130,031
Imprecision 110,410
Premature End-of-Life Indicator 107,329
Unintended Application Program Shut Down 70,511
Protective Measures Problem 58,884
Appropriate Device Problem Term/Code Not Available 36,363
Communication or Transmission Problem 30,896
Break 25,398
Device Displays Incorrect Message 21,642
Inappropriate or Unexpected Reset 21,345
Unexpected Shutdown 16,997
No Audible Alarm 16,598
High Readings 15,705
Defective Alarm 15,664
Unable to Obtain Readings 13,733
Display or Visual Feedback Problem 11,819

Yearly Trend

07
2007: 3
18
2018: 37,106
19
2019: 80,774
20
2020: 200,738
21
2021: 254,833
22
2022: 232,288
23
2023: 273,564
24
2024: 347,122
25
2025: 379,890
26
2026: 367,877

Reports in 2025 (379,890) held close to the prior two-year average of 310,343.

Related Entities for Integrated Continuous Glucose Monitoring System, Factory Calibrated

Top Manufacturers

DEXCOM, INC. 1,969,172
ABBOTT DIABETES CARE INC 101,255
ABBOTT DIABETES CARE LTD 84,512
Dexcom, Inc. 9,905
Abbott Diabetes Care Inc 3,969
Abbott Diabetes Care Ltd 2,098
ABBOTT DIABETES CARE INC. 1,462
DEXCOM INC. 455
ABBOTT DIABETES CARE, INC. 181

Event Locations

1,651,092 (75.9%)
I 522,715 (24.0%)
NO INFORMATION 386 (0.0%)
HOSPITAL 1 (0.0%)
N 1 (0.0%)

Compare DEXCOM, INC. vs ABBOTT DIABETES CARE INC →

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 (2,174,195 here).

Pump, Infusion 1,827,009 Alternate Controller Enabled Insulin Infusi… 1,260,826 Pump 890,539 Automated Insulin Dosing Device System 885,752

Similar death-typed counts

Nearest other device types by death-typed report count (226 here), distinct from the volume row.

Suture 226 System, Hemodynamic, Implantable 226 Pump, Infusion, Pca 225 Shunt, Central Nervous System And Components 222

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.