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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#28 of 1000 · 146,937 reports · 2020–2026

  • BOOK 146,937 reports
  • RANK #28 of 1000
  • DEATH 27 death-typed
  • INJ 40,638 injury-typed
  • MALF 106,265 malfunction
  • SPAN 2020–2026
  • PEAK 2023: 39,321
  • PHOTO Implantable Pulse Gen…

Nearest event-volume peer: Implantable Pulse Generator, Pacemaker (Non-Crt) (639 report gap)

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems sits #28 of 1000 among tracked device types with 146,937 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 →

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 27.7% corpus 30.4% · below corpus mean (-2.8 pp)
  • MALF 72.3% corpus 64.5% · above corpus mean (+7.8 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 62% of coded problems · Lead manufacturer ABBOTT DIABETES CARE INC accounts for 87% of manufacturer-tagged reports · Top event location is 88% 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, Not For Use With Automated Insulin Delivery Systems carries 146,937 MAUDE reports, ranked #28 of 1000.

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

Event Types

Malfunction 106,265 (72.3%)
Injury 40,638 (27.7%)
Death 27 (0.0%)
Other 6 (0.0%)
1 (0.0%)

Patient Outcomes

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

107,144 (72.4%)
Required Intervention 33,809 (22.9%)
Other 5,205 (3.5%)
R 615 (0.4%)
Hospitalization 613 (0.4%)
H 424 (0.3%)
O 31 (0.0%)
Life Threatening 27 (0.0%)
Death 25 (0.0%)
S 15 (0.0%)
Disability 15 (0.0%)
L 14 (0.0%)
D 2 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 101,570
Unable to Obtain Readings 18,122
Device Displays Incorrect Message 17,794
Low Readings 5,321
High Readings 5,029
Detachment of Device or Device Component 4,419
Product Quality Problem 3,880
Device Alarm System 3,395
Adverse Event Without Identified Device or Use Problem 2,781
Failure to Power Up 957
Application Program Problem 509
Premature Discharge of Battery 244
Failure to Fire 152
Material Twisted/Bent 135
No Audible Alarm 130
No Device Output 128
Unintended Electrical Shock 112
Power Problem 95
Difficult to Insert 67
Appropriate Term/Code Not Available 65

Yearly Trend

20
2020: 1,069
21
2021: 22,500
22
2022: 26,528
23
2023: 39,321
24
2024: 35,116
25
2025: 20,535
26
2026: 1,868

Related Entities for Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Top Manufacturers

ABBOTT DIABETES CARE INC 127,323
ABBOTT DIABETES CARE LTD 19,143
ABBOTT DIABETES CARE INC. 315
ABBOTT DIABETES CARE, INC. 24
UNK 6

Event Locations

128,585 (87.5%)
I 18,349 (12.5%)
NO INFORMATION 3 (0.0%)

Compare ABBOTT DIABETES CARE INC vs ABBOTT DIABETES CARE LTD →

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 (146,937 here).

Implantable Pulse Generator, Pacemaker 147,576 Wearable Automated External Defibrillator 143,491 Ventricular Bypass 153,365 Prosthesis 153,958

Similar death-typed counts

Nearest other device types by death-typed report count (27 here), distinct from the volume row.

Instrument, Biopsy 27 Apparatus, Nitric Oxide Delivery 28 Biopsy Needle 26 Catheter 26

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.