Devices › Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Device brand name · Flash glucose monitoring system
FreeStyle Libre: medical device reports filed with FDA
6,045 reports name it, 2017–2026. Manufacturer given most often on reports: Abbott Diabetes Care. Product code PZE.
- 6,045
- device reports naming the brand
- 0% of all MAUDE reports · about 705 a year
- 1,560
- reports, 12 months to August 2026
- 446 in the 12 months before
- 50%
- classified as malfunction
- 86.9% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 6,045 reports that name the brand "FreeStyle Libre" (flash glucose monitoring system), received between December 2017 and August 2026; the manufacturer given most often on reports is Abbott Diabetes Care. Spellings of one product vary from report to report.
1,560 reports arrived in the 12 months to August 2026, up 250% from 446 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 (50%) and injury (49.9%); across all sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated reports (product code PZE) death is recorded in 0% and malfunction in 86.9%. 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 (44.7%), high readings (6.2%) and low readings (5.8%). The patient problems coded most often are skin irritation, hypoglycemia and itching sensation. 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 133,421 reports carrying product code PZE. 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 | 2,701 | 44.7% | 80.2% |
| High readingsreadings were too high | 376 | 6.2% | 2.4% |
| Low readingsreadings were too low | 352 | 5.8% | 2.1% |
| Device displays incorrect message | 326 | 5.4% | 3.1% |
| Product quality problem | 264 | 4.4% | 0.8% |
| Unable to obtain readings | 131 | 2.2% | 2.9% |
| Detachment of device or device componentpart of the device came off | 111 | 1.8% | 0.9% |
| Failure to power up | 50 | 0.8% | 0.2% |
| No device output | 26 | 0.4% | 0.1% |
| Device alarm system | 23 | 0.4% | 5.6% |
| No display/image | 17 | 0.3% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 11 | 0.2% | 0% |
| Battery problema problem with the battery | 8 | 0.1% | 0% |
| Unintended electrical shock | 8 | 0.1% | 0% |
| Insufficient device problem information | 5 | 0.1% | 0% |
| Failure to fire | 4 | 0.1% | 0% |
| Premature discharge of battery | 4 | 0.1% | 0% |
| Connection problema connection problem | 3 | 0% | 0% |
| Defective devicethe device was defective | 3 | 0% | 0% |
| Display or visual feedback problem | 3 | 0% | 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 |
|---|---|---|
| Skin irritationirritated skin | 1,243 | 20.6% |
| Hypoglycemialow blood sugar | 786 | 13% |
| Itching sensation | 561 | 9.3% |
| Loss of consciousnesspassing out | 445 | 7.4% |
| Erythemaskin redness | 419 | 6.9% |
| Hyperglycemiahigh blood sugar | 379 | 6.3% |
| Painpain, site not specified | 166 | 2.7% |
| Dizzinesslight-headedness or unsteadiness | 100 | 1.7% |
| Purulent discharge | 99 | 1.6% |
| Rashskin rash | 93 | 1.5% |
| Sweating | 90 | 1.5% |
| Shaking/tremors | 84 | 1.4% |
| Elevated ketones/ diabetic ketoacidosis | 79 | 1.3% |
| Seizures | 77 | 1.3% |
| Swellingswelling | 59 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | FreeStyle Libre | Product code PZE | All MAUDE reports |
|---|---|---|---|
| Reports | 6,045 | 133,421 | 26,136,888 |
| Share of that pool | — | 4.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 49.9% | 13.1% | 36.2% |
| Classified as malfunction | 50% | 86.9% | 62.3% |
| Filed by the manufacturer | 98.7% | 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 PZE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Libre Sensor Freestyle | 77,781 | 12 | 0% |
| Freestyle Libre 14 Day | 25,865 | 10,976 | 0% |
| FreeStyle Libre Sensor 14 Day | 13,296 | 117 | 0% |
| FreeStyle LibreLink | 8,145 | 6,512 | 0% |
| FreeStyle Libre Sensor | 801 | 11 | 0% |
| Libre 2 Sensor FreeStyle | 76,420 | 3 | 0% |
| FreeStyle Libre App | 156 | 156 | 0% |
| FreeStyle Libre 2 | 113,658 | 67,297 | 0% |
| Fs Opt-No Coding | 170 | 0 | 0% |
| FreeStyle Libre 2 Plus | 49,668 | 45,839 | 0% |
| FreeStyle Libre 2 Sensor | 228 | 52 | 3.1% |
| Libre 3 Sensor FreeStyle | 12,829 | 2 | 0% |
| FreeStyle Libre 3 Plus | 91,348 | 88,323 | 0% |
| Freestyle | 9,490 | 26 | 0.1% |
| Freestyle Freedom | 3,430 | 6 | 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 reports
How many FDA reports name FreeStyle Libre?
6,045 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,560 in the latest 12 months.
What kinds of events are reported?
malfunction (50%) and injury (49.9%). "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 (44.7%), high readings (6.2%), low readings (5.8%), device displays incorrect message (5.4%) and product quality problem (4.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%) and voluntary reports (1.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that FreeStyle Libre 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.