2026 data FDA MAUDE openFDA

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

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 Monitor For N… LIGHT-BOOK · MAUDE

#492 of 1000 · 1,969 reports · 2024–2026

  • BOOK 1,969 reports
  • RANK #492 of 1000
  • DEATH 0 death-typed
  • INJ 155 injury-typed
  • MALF 1,814 malfunction
  • SPAN 2024–2026
  • PEAK 2025: 1,506
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Suction, Ward Use, Portable, Ac-Powered (6 report gap)

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter sits #492 of 1000 among tracked device types with 1,969 MAUDE reports spanning 2024–2026. 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 7.9% corpus 30.4% · below corpus mean (-22.6 pp)
  • MALF 92.1% corpus 64.5% · above corpus mean (+27.6 pp)

Lead product-problem code Detachment of Device or Device Component is 61% of coded problems · Lead manufacturer DEXCOM, INC. accounts for 97% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Integrated Continuous Glucose Monitor For N… in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter carries 1,969 MAUDE reports, ranked #492 of 1000.

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

Event Types

Malfunction 1,814 (92.1%)
Injury 155 (7.9%)

Patient Outcomes

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

1,799 (91.5%)
Other 128 (6.5%)
Required Intervention 28 (1.4%)
O 5 (0.3%)
Hospitalization 2 (0.1%)
Life Threatening 2 (0.1%)
H 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Detachment of Device or Device Component 1,226
Break 366
Appropriate Term/Code Not Available 176
Adverse Event Without Identified Device or Use Problem 93
Incorrect, Inadequate or Imprecise Result or Readings 48
Wireless Communication Problem 17
High Readings 14
Defective Device 11
Device Sensing Problem 11
Therapeutic or Diagnostic Output Failure 9
Low Readings 7
Activation Failure 6
Unexpected Shutdown 6
Activation, Positioning or Separation Problem 4
Delivered as Unsterile Product 4
Product Quality Problem 4
Unable to Obtain Readings 4
Display or Visual Feedback Problem 3
False Alarm 3
Patient Device Interaction Problem 3

Yearly Trend

24
2024: 249
25
2025: 1,506
26
2026: 214

Related Entities for Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Event Locations

1,969 (100.0%)

Compare DEXCOM, INC. vs ABBOTT DIABETES CARE INC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Integrated Continuous Glucose Monitor For N…, 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 (1,969 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Integrated Continuous Glucose Monitor For N… 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 Monitor For N…; 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.