Devices › Integrated continuous glucose monitoring system with sensor containing dexamethasone acetate
Device brand name · Eversense continuous glucose monitor system
Eversense Sensor: medical device reports filed with FDA
6,535 reports name it, 2018–2026. Manufacturer given most often on reports: Senseonics. Product code SBA.
- 6,535
- device reports naming the brand
- 0% of all MAUDE reports · about 844 a year
- 3,183
- reports, 12 months to August 2026
- 1,338 in the 12 months before
- 67%
- classified as malfunction
- 77.8% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
6,535 medical device reports received by FDA name the brand "Eversense Sensor" (eversense continuous glucose monitor system); the manufacturer given most often on reports is Senseonics; received from October 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
3,183 reports arrived in the 12 months to August 2026, up 138% from 1,338 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 (67%) and injury (32.9%); across all integrated continuous glucose monitoring system with sensor containing dexamethasone acetate reports (product code SBA) death is recorded in 0% and malfunction in 77.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are imprecision (45.8%), failure to sense (13.7%) and difficult to remove (7.4%). The patient problems coded most often are discomfort, skin infection and hypoglycemia. 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 3,494 reports carrying product code SBA. 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 |
|---|---|---|---|
| Imprecision | 2,996 | 45.8% | 70.2% |
| Failure to sense | 896 | 13.7% | 0.4% |
| Difficult to removethe device was hard to remove | 483 | 7.4% | 1.4% |
| Premature end-of-life indicator | 343 | 5.2% | 2.1% |
| Output problem | 285 | 4.4% | 7.2% |
| Communication or transmission problemthe device could not communicate or transmit | 196 | 3% | 4.2% |
| Material separation | 138 | 2.1% | 0.5% |
| Device sensing problem | 62 | 0.9% | 0.1% |
| Connection problema connection problem | 57 | 0.9% | 0.6% |
| Insufficient device problem information | 33 | 0.5% | 0.6% |
| Unable to obtain readings | 30 | 0.5% | 0.9% |
| Installation-related problem | 19 | 0.3% | 0.1% |
| Optical problem | 16 | 0.2% | 0% |
| Calibration problem | 10 | 0.2% | 0.2% |
| Improper or incorrect procedure or method | 7 | 0.1% | 0% |
| Environmental compatibility problem | 5 | 0.1% | 0% |
| Chemical problem | 4 | 0.1% | 0% |
| Device ingredient or reagent problem | 4 | 0.1% | 0% |
| Incorrect, inadequate or imprecise result or readings | 4 | 0.1% | 0.1% |
| Wireless communication problema wireless connection problem | 4 | 0.1% | 0.1% |
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 |
|---|---|---|
| Discomfortdiscomfort | 520 | 8% |
| Skin infection | 245 | 3.7% |
| Hypoglycemialow blood sugar | 213 | 3.3% |
| Hyperglycemiahigh blood sugar | 145 | 2.2% |
| Skin inflammation/ irritation | 136 | 2.1% |
| Painpain, site not specified | 134 | 2.1% |
| Abscessa collection of pus | 55 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 55 | 0.8% |
| Swelling/ edema | 53 | 0.8% |
| Hemorrhage/blood loss/bleeding | 48 | 0.7% |
| Implant pain | 46 | 0.7% |
| Post operative wound infection | 26 | 0.4% |
| Elevated ketones/ diabetic ketoacidosis | 24 | 0.4% |
| Fluid discharge | 18 | 0.3% |
| Bruise/contusion | 16 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Eversense Sensor | Product code SBA | All MAUDE reports |
|---|---|---|---|
| Reports | 6,535 | 3,494 | 26,136,888 |
| Share of that pool | — | 187% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 32.9% | 22.1% | 36.2% |
| Classified as malfunction | 67% | 77.8% | 62.3% |
| Filed by the manufacturer | 100% | 100% | 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 SBA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| EverSense Transmitter | 704 | 18 | 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 Eversense Sensor reports
How many FDA reports name Eversense Sensor?
6,535 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3,183 in the latest 12 months.
What kinds of events are reported?
malfunction (67%) and injury (32.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
imprecision (45.8%), failure to sense (13.7%), difficult to remove (7.4%), premature end-of-life indicator (5.2%) and output problem (4.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Eversense 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.