2026 data FDA MAUDE openFDA FDA Class I

Continuous Glucose Monitor Retrospective Data Analysis Software

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §862.2120 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book Continuous Glucose Monitor Retrospective Da… LIGHT-BOOK · MAUDE

#493 of 1000 · 2,060 reports · 2017–2026

  • BOOK 2,060 reports
  • RANK #493 of 1000
  • DEATH 0 death-typed
  • INJ 8 injury-typed
  • MALF 2,052 malfunction
  • SPAN 2017–2026
  • PEAK 2023: 820
  • PHOTO Ligator, Hemorrhoidal

Nearest event-volume peer: Ligator, Hemorrhoidal (2 report gap)

Continuous Glucose Monitor Retrospective Data Analysis Software sits #493 of 1000 among tracked device types with 2,060 MAUDE reports spanning 2017–2026. 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

Continuous Glucose Monitor Retrospective Da… carries 99.6% MALFUNCTION-coded reports, 34.8pp 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 0.4% corpus 30.3% · below corpus mean (-29.9 pp)
  • MALF 99.6% corpus 64.8% · above corpus mean (+34.8 pp)

Lead product-problem code Computer Software Problem is 79% of coded problems · Lead manufacturer MEDTRONIC MINIMED accounts for 99% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .

Continuous Glucose Monitor Retrospective Da… in the event-volume neighbourhood

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

reports

What this shows Continuous Glucose Monitor Retrospective Data Analysis Software carries 2,060 MAUDE reports, ranked #493 of 1000.

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

Event Types

Malfunction 2,052 (99.6%)
Injury 8 (0.4%)

Patient Outcomes

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

2,023 (99.4%)
Other 8 (0.4%)
Required Intervention 4 (0.2%)
R 1 (0.0%)

Top Product Problems

Computer Software Problem 1,750
Data Problem 225
Wireless Communication Problem 110
Appropriate Device Problem Term/Code Not Available 62
Communication or Transmission Problem 18
Problem with Software Installation 15
No Apparent Adverse Event 14
Unauthorized Access to Computer System 8
Application Network Problem 5
Application Program Problem 5
Incorrect, Inadequate or Imprecise Result or Readings 5
Computer Operating System Problem 2
Adverse Event Without Identified Device or Use Problem 1
Application Program Freezes or Fails to Launch 1
Calibration Problem 1
Device Displays Incorrect Message 1
Device Operates Differently Than Expected 1
Device-Device Incompatibility 1
Failure to Transmit Record 1
Fluid/Blood Leak 1

Yearly Trend

17
2017: 1
18
2018: 5
19
2019: 5
20
2020: 1
21
2021: 4
22
2022: 674
23
2023: 820
24
2024: 284
25
2025: 170
26
2026: 96

Reports fell to 170 in 2025, down from an average of 552 in the two years before.

Related Entities for Continuous Glucose Monitor Retrospective Data Analysis Software

Event Locations

2,044 (99.2%)
NO INFORMATION 9 (0.4%)
I 7 (0.3%)

Compare MEDTRONIC MINIMED vs DEXCOM, INC. →

Nationwide devices with a comparable report-volume footprint

Continuous Glucose Monitor Retrospective Da… carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,060 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 Continuous Glucose Monitor Retrospective Da… 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 Continuous Glucose Monitor Retrospective Da…; 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.