Devices › Glucose dehydrogenase, glucose
Device brand name · Blood glucose monitoring system
Freestyle: medical device reports filed with FDA
9,490 reports name it, 2001–2026. Manufacturer given most often on reports: Abbott Diabetes Care USA. Product code LFR.
- 9,490
- device reports naming the brand
- 0% of all MAUDE reports · about 377 a year
- 26
- reports, 12 months to August 2026
- 31 in the 12 months before
- 85.8%
- classified as malfunction
- 93% across the product code
- 0.1%
- classified as death, as reported
- 14 reports · not verified by FDA
9,490 medical device reports received by FDA name the brand "Freestyle" (blood glucose monitoring system); the manufacturer given most often on reports is Abbott Diabetes Care USA; received from May 2001 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
26 reports arrived in the 12 months to August 2026, down 16% from 31 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 (85.8%), injury (14%) and death (0.1%); across all glucose dehydrogenase, glucose reports (product code LFR) death is recorded in 0% and malfunction in 93%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are use of incorrect control/treatment settings (40.6%), loss of data (13.9%) and incorrect or inadequate test results (13.5%). The patient problems coded most often are therapy/non-surgical treatment, additional, treatment with medication(s) and hospitalization required. 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 74,282 reports carrying product code LFR. 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 |
|---|---|---|---|
| Use of incorrect control/treatment settings | 3,851 | 40.6% | 17.6% |
| Loss of data | 1,315 | 13.9% | 6.6% |
| Incorrect or inadequate test results | 1,277 | 13.5% | 25.8% |
| Device displays incorrect message | 913 | 9.6% | 3.8% |
| Computer operating system problem | 819 | 8.6% | 3.4% |
| Battery problema problem with the battery | 712 | 7.5% | 3% |
| Reset problem | 711 | 7.5% | 3% |
| Device issuea problem with the device | 472 | 5% | 2.2% |
| High test results | 449 | 4.7% | 4% |
| Malfunction | 334 | 3.5% | 1.6% |
| Nonstandard device | 277 | 2.9% | 0.4% |
| Insufficient device problem information | 244 | 2.6% | 0.3% |
| Computer software problema software problem | 214 | 2.3% | 0.9% |
| Low test results | 209 | 2.2% | 1.6% |
| Computer hardware error | 208 | 2.2% | 0.9% |
| Low readingsreadings were too low | 183 | 1.9% | 0.3% |
| Self-activation or keying | 150 | 1.6% | 0.6% |
| Failure to power up | 136 | 1.4% | 0.3% |
| No display/image | 119 | 1.3% | 0.8% |
| Battery failure | 93 | 1% | 0.5% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 487 | 5.1% |
| Treatment with medication(s) | 454 | 4.8% |
| Hospitalization required | 380 | 4% |
| Hypoglycemialow blood sugar | 304 | 3.2% |
| Loss of consciousnesspassing out | 292 | 3.1% |
| Blood glucose, low | 285 | 3% |
| Hyperglycemiahigh blood sugar | 136 | 1.4% |
| Dizzinesslight-headedness or unsteadiness | 133 | 1.4% |
| Seizures | 113 | 1.2% |
| Aortic valve insufficiency/ regurgitation | 112 | 1.2% |
| Sweating | 105 | 1.1% |
| Blood glucose, high | 101 | 1.1% |
| Shaking/tremors | 92 | 1% |
| Aortic valve stenosis | 83 | 0.9% |
| Other (for use when an appropriate patient code cannot be identified) | 58 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Freestyle | Product code LFR | All MAUDE reports |
|---|---|---|---|
| Reports | 9,490 | 74,282 | 26,136,888 |
| Share of that pool | — | 12.8% | 0% |
| Classified as death, per 1,000 reports | 1 | 0 | 9 |
| Classified as injury | 14% | 6.9% | 36.2% |
| Classified as malfunction | 85.8% | 93% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 LFR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Freestyle Flash | 19,422 | 0 | 0% |
| Accu-Chek Comfort Curve Test Strips | 13,065 | 0 | 0% |
| Accu-Chek Aviva Test Strips | 11,073 | 0 | 0% |
| Accu-Chek Compact Test Drum | 7,579 | 0 | 0% |
| Accu-Chek Aviva Plus Test Strips | 7,947 | 0 | 0% |
| Accu-Chek Mobile Test Strips | 3,527 | 0 | 0% |
| Accu-Chek Performa Test Strips | 3,886 | 1 | 0% |
| Accu-Chek Active Test Strips | 1,475 | 0 | 0% |
| Accu-Chek Comfort Curve | 4,120 | 0 | 0.6% |
| FreeStyle Lite | 12,244 | 430 | 0% |
| Freestyle Freedom | 3,430 | 6 | 0% |
| Accu-Chek Guide | 772 | 365 | 0% |
| Accu-Chek Smartview Test Strips | 993 | 0 | 0% |
| Freestyle Navigator | 754 | 0 | 0% |
| Accu-Chek Compact Plus Test Drum | 769 | 0 | 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 reports
How many FDA reports name Freestyle?
9,490 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 26 in the latest 12 months.
What kinds of events are reported?
malfunction (85.8%), injury (14%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
use of incorrect control/treatment settings (40.6%), loss of data (13.9%), incorrect or inadequate test results (13.5%), device displays incorrect message (9.6%) and computer operating system problem (8.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Freestyle 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.