Devices › Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
Device brand name · Flash glucose monitoring system
FreeStyle Libre 2 Sensor: medical device reports filed with FDA
228 reports name it, 2021–2026. Manufacturer given most often on reports: Abbott Diabetes Care. Product code QLG.
- 228
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 52
- reports, 12 months to August 2026
- 44 in the 12 months before
- 73.2%
- classified as malfunction
- 80.3% across the product code
- 3.1%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 228 reports that name the brand "FreeStyle Libre 2 Sensor" (flash glucose monitoring system), received between February 2021 and August 2026; the manufacturer given most often on reports is Abbott Diabetes Care. Spellings of one product vary from report to report.
52 reports arrived in the 12 months to August 2026, up 18% from 44 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 (73.2%), injury (21.5%) and death (3.1%); across all integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems reports (product code QLG) death is recorded in 0% and malfunction in 80.3%. 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 (53.1%), defective device (5.7%) and device displays incorrect message (4.8%). The patient problems coded most often are hypoglycemia, hyperglycemia and loss of consciousness. 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 213,812 reports carrying product code QLG. 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 | 121 | 53.1% | 73.8% |
| Defective devicethe device was defective | 13 | 5.7% | 0% |
| Device displays incorrect message | 11 | 4.8% | 8.4% |
| Activation failure | 10 | 4.4% | 0% |
| Therapeutic or diagnostic output failure | 9 | 3.9% | 0% |
| Unable to obtain readings | 9 | 3.9% | 8.6% |
| Product quality problem | 8 | 3.5% | 1.9% |
| Manufacturing, packaging or shipping problem | 5 | 2.2% | 0% |
| Detachment of device or device componentpart of the device came off | 4 | 1.8% | 2.1% |
| Display or visual feedback problem | 4 | 1.8% | 0% |
| Component or accessory incompatibility | 3 | 1.3% | 0% |
| Defective component | 3 | 1.3% | 0% |
| Device sensing problem | 3 | 1.3% | 0% |
| Device-device incompatibility | 3 | 1.3% | 0% |
| Output problem | 3 | 1.3% | 0% |
| Unexpected shutdown | 3 | 1.3% | 0% |
| Compatibility problem | 2 | 0.9% | 0% |
| Insufficient device problem information | 2 | 0.9% | 0% |
| Low test results | 2 | 0.9% | 0% |
| Material protrusion/extrusion | 2 | 0.9% | 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 |
|---|---|---|
| Hypoglycemialow blood sugar | 18 | 7.9% |
| Hyperglycemiahigh blood sugar | 12 | 5.3% |
| Loss of consciousnesspassing out | 9 | 3.9% |
| Coma | 6 | 2.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 1.8% |
| Erythemaskin redness | 3 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.3% |
| Bruise/contusion | 2 | 0.9% |
| Convulsion/seizure | 2 | 0.9% |
| Diaphoresis | 2 | 0.9% |
| Anxietyanxiety | 1 | 0.4% |
| Cancer | 1 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.4% |
| Confusion/ disorientation | 1 | 0.4% |
| Decreased level of consciousness | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | FreeStyle Libre 2 Sensor | Product code QLG | All MAUDE reports |
|---|---|---|---|
| Reports | 228 | 213,812 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 31 | 0 | 9 |
| Classified as injury | 21.5% | 19.7% | 36.2% |
| Classified as malfunction | 73.2% | 80.3% | 62.3% |
| Filed by the manufacturer | 56.1% | 99.8% | 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 QLG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| FreeStyle Libre 2 | 113,658 | 67,297 | 0% |
| Libre 2 Sensor FreeStyle | 76,420 | 3 | 0% |
| FreeStyle Libre 3 | 120,677 | 103,045 | 0% |
| Libre 3 Sensor FreeStyle | 12,829 | 2 | 0% |
| Instinct | 1,215 | 1,171 | 0% |
| FreeStyle Libre Select | 1,068 | 1,063 | 0% |
| FreeStyle Libre 3 Plus | 91,348 | 88,323 | 0% |
| FreeStyle Libre 2 Plus | 49,668 | 45,839 | 0% |
| FreeStyle Libre 3 Sensor | 273 | 74 | 1.5% |
| Libre 2 Plus Sensor FreeStyle | 808 | 10 | 0% |
| Fs Opt-No Coding | 170 | 0 | 0% |
| FreeStyle LibreLink | 8,145 | 6,512 | 0% |
| Freestyle Libre 14 Day | 25,865 | 10,976 | 0% |
| Libre 3 Plus Sensor Freestyle | 585 | 13 | 0% |
| FreeStyle Libre 2 Plus Sensor | 3,929 | 2,799 | 0% |
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 2 Sensor reports
How many FDA reports name FreeStyle Libre 2 Sensor?
228 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 52 in the latest 12 months.
What kinds of events are reported?
malfunction (73.2%), injury (21.5%) and death (3.1%). "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 (53.1%), defective device (5.7%), device displays incorrect message (4.8%), activation failure (4.4%) and therapeutic or diagnostic output failure (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (56.1%) and voluntary reports (43.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that FreeStyle Libre 2 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.