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Device brand name · Integrated continuous glucose monitoring system factory calibrated
Freestyle Libre 3 Plus Sensor: medical device reports filed with FDA
163 reports name it, 2024–2026. Manufacturer given most often on reports: Abbott Diabetes Care. Product code QBJ.
- 163
- device reports naming the brand
- 0% of all MAUDE reports · about 89 a year
- 96
- reports, 12 months to August 2026
- 67 in the 12 months before
- 77.9%
- classified as malfunction
- 98.1% across the product code
- 2.5%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 163 reports that name the brand "Freestyle Libre 3 Plus Sensor" (integrated continuous glucose monitoring system factory calibrated), received between September 2024 and August 2026; the manufacturer given most often on reports is Abbott Diabetes Care. Spellings of one product vary from report to report.
96 reports arrived in the 12 months to August 2026, up 43% from 67 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (77.9%), injury (18.4%) and death (2.5%); across all integrated continuous glucose monitoring system, factory calibrated reports (product code QBJ) death is recorded in 0% and malfunction in 98.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (46.6%), low readings (15.3%) and nonstandard device (12.3%). The patient problems coded most often are hyperglycemia, hypoglycemia and skin inflammation/ irritation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,268,325 reports carrying product code QBJ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 76 | 46.6% | 10.4% |
| Low readingsreadings were too low | 25 | 15.3% | 7.1% |
| Nonstandard device | 20 | 12.3% | 0% |
| Defective devicethe device was defective | 16 | 9.8% | 0% |
| Device sensing problem | 12 | 7.4% | 0% |
| High readingsreadings were too high | 8 | 4.9% | 0.7% |
| Therapeutic or diagnostic output failure | 8 | 4.9% | 0% |
| Computer software problema software problem | 4 | 2.5% | 0% |
| False alarm | 4 | 2.5% | 0% |
| Product quality problem | 4 | 2.5% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 1.8% | 1.4% |
| Premature separation | 2 | 1.2% | 0% |
| Detachment of device or device componentpart of the device came off | 1 | 0.6% | 5.8% |
| Device displays incorrect message | 1 | 0.6% | 1% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.6% | 0% |
| Display or visual feedback problem | 1 | 0.6% | 0.5% |
| Electrical /electronic property probleman electrical or electronic problem | 1 | 0.6% | 0% |
| Insufficient device problem information | 1 | 0.6% | 0% |
| Operating system becomes nonfunctional | 1 | 0.6% | 0% |
| Separation failure | 1 | 0.6% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperglycemiahigh blood sugar | 13 | 8% |
| Hypoglycemialow blood sugar | 7 | 4.3% |
| Skin inflammation/ irritation | 3 | 1.8% |
| Alteration in body temperature | 1 | 0.6% |
| Arrhythmia | 1 | 0.6% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
| Diaphoresis | 1 | 0.6% |
| Elevated ketones/ diabetic ketoacidosis | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| Hypersensitivity/allergic reaction | 1 | 0.6% |
| Itching sensation | 1 | 0.6% |
| Lethargysluggishness | 1 | 0.6% |
| Loss of consciousnesspassing out | 1 | 0.6% |
| Malaisegeneral feeling of being unwell | 1 | 0.6% |
| Multiple organ dysfunction syndromeseveral organs failing | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Freestyle Libre 3 Plus Sensor | Product code QBJ | All MAUDE reports |
|---|---|---|---|
| Reports | 163 | 2,268,325 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 25 | 0 | 9 |
| Classified as injury | 18.4% | 1.9% | 36.2% |
| Classified as malfunction | 77.9% | 98.1% | 62.3% |
| Filed by the manufacturer | 37.4% | 99.7% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code QBJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitoring System | 1,339,562 | 61,710 | 0% |
| Dexcom G7 Continuous Glucose Monitoring System | 641,507 | 268,781 | 0% |
| FreeStyle Libre 3 | 120,677 | 103,045 | 0% |
| FreeStyle Libre 3 Plus | 91,348 | 88,323 | 0% |
| FreeStyle Libre 2 Plus | 49,668 | 45,839 | 0% |
| Dexcom G7 15 Day Continuous Glucose Monitoring System | 13,869 | 13,869 | 0% |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring System | 5,664 | 1,759 | 0% |
| Libre 3 Sensor FreeStyle | 12,829 | 2 | 0% |
| FreeStyle Libre 2 Plus Sensor | 3,929 | 2,799 | 0% |
| Dexcom G6 Mobile Continuous Glucose Monitoring System | 1,833 | 0 | 0% |
| Dexcom ONE Continuous Glucose Monitoring System | 1,550 | 189 | 0% |
| Dexcom G7 | 1,394 | 583 | 0.1% |
| Libre 2 Plus Sensor FreeStyle | 808 | 10 | 0% |
| Libre 3 Plus Sensor Freestyle | 585 | 13 | 0% |
| Dexcom G7 Sensor | 436 | 137 | 0.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Freestyle Libre 3 Plus Sensor reports
How many FDA reports name Freestyle Libre 3 Plus Sensor?
163 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 96 in the latest 12 months.
What kinds of events are reported?
malfunction (77.9%), injury (18.4%) and death (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (46.6%), low readings (15.3%), nonstandard device (12.3%), defective device (9.8%) and device sensing problem (7.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (62.6%) and manufacturer reports (37.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Freestyle Libre 3 Plus Sensor was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.