Devices › Glucose dehydrogenase, glucose
Device brand name · Continuous glucose monitoring system
Freestyle Navigator: medical device reports filed with FDA
754 reports name it, 2008–2014. Manufacturer given most often on reports: Abbott Diabetes Care USA. Product code LFR.
- 754
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 90.1%
- classified as malfunction
- 93% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
754 medical device reports received by FDA name the brand "Freestyle Navigator" (continuous glucose monitoring system); the manufacturer given most often on reports is Abbott Diabetes Care USA; received from October 2008 to November 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (90.1%) and injury (9.9%); 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 crack (69.5%), moisture damage (12.6%) and fracture (8.9%). The patient problems coded most often are loss of consciousness, hypoglycemia and seizures. 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
No report naming Freestyle Navigator was received in the five years to August 2026; the latest was received in November 2014.
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 |
|---|---|---|---|
| Crackthe device cracked | 524 | 69.5% | 0.6% |
| Moisture damage | 95 | 12.6% | 0.1% |
| Fracturea broken bone | 67 | 8.9% | 0.1% |
| Breakthe device broke | 32 | 4.2% | 0% |
| Connection problema connection problem | 17 | 2.3% | 0% |
| Moisture or humidity problem | 12 | 1.6% | 0% |
| High test results | 11 | 1.5% | 4% |
| Insufficient device problem information | 11 | 1.5% | 0.3% |
| Device alarm system | 10 | 1.3% | 0% |
| Incorrect or inadequate test results | 10 | 1.3% | 25.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 1.2% | 0.1% |
| Detachment of device component | 8 | 1.1% | 0% |
| Device displays incorrect message | 7 | 0.9% | 3.8% |
| Contamination | 5 | 0.7% | 0% |
| Corrodedthe device corroded | 4 | 0.5% | 0% |
| Device contamination with biological material | 4 | 0.5% | 0% |
| Loose or intermittent connection | 4 | 0.5% | 0% |
| Battery problema problem with the battery | 3 | 0.4% | 3% |
| Failure to calibrate | 3 | 0.4% | 0% |
| No display/image | 3 | 0.4% | 0.8% |
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 |
|---|---|---|
| Loss of consciousnesspassing out | 36 | 4.8% |
| Hypoglycemialow blood sugar | 34 | 4.5% |
| Seizures | 19 | 2.5% |
| Therapy/non-surgical treatment, additional | 10 | 1.3% |
| Treatment with medication(s) | 7 | 0.9% |
| Confusion/ disorientation | 5 | 0.7% |
| Sweating | 4 | 0.5% |
| Abscessa collection of pus | 3 | 0.4% |
| Dizzinesslight-headedness or unsteadiness | 3 | 0.4% |
| Falla fall | 3 | 0.4% |
| Hyperglycemiahigh blood sugar | 3 | 0.4% |
| Painpain, site not specified | 3 | 0.4% |
| Bruise/contusion | 2 | 0.3% |
| Erythemaskin redness | 2 | 0.3% |
| Fatiguetiredness | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Freestyle Navigator | Product code LFR | All MAUDE reports |
|---|---|---|---|
| Reports | 754 | 74,282 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 9.9% | 6.9% | 36.2% |
| Classified as malfunction | 90.1% | 93% | 62.3% |
| Filed by the manufacturer | 99.6% | 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% |
| Freestyle | 9,490 | 26 | 0.1% |
| 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% |
| 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 Navigator reports
How many FDA reports name Freestyle Navigator?
754 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (90.1%) and injury (9.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
crack (69.5%), moisture damage (12.6%), fracture (8.9%), break (4.2%) and connection problem (2.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Freestyle Navigator 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.