Devices › Integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter
Device brand name · Continuous glucose monitor
Stelo Glucose Biosensor System: medical device reports filed with FDA
2,508 reports name it, 2024–2026. Manufacturer given most often on reports: Dexcom. Product code SAF.
- 2,508
- device reports naming the brand
- 0% of all MAUDE reports · about 1,373 a year
- 1,271
- reports, 12 months to August 2026
- 1,237 in the 12 months before
- 94.7%
- classified as malfunction
- 91.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
2,508 medical device reports received by FDA name the brand "Stelo Glucose Biosensor System" (continuous glucose monitor); the manufacturer given most often on reports is Dexcom; received from September 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,271 reports arrived in the 12 months to August 2026, close to the 1,237 of 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 (94.7%) and injury (5.3%); across all integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter reports (product code SAF) death is recorded in 0% and malfunction in 91.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (62.9%), break (18.8%) and incorrect, inadequate or imprecise result or readings (0.6%). The patient problems coded most often are foreign body in patient, pain and erythema. 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 2,699 reports carrying product code SAF. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 1,578 | 62.9% | 58.7% |
| Breakthe device broke | 471 | 18.8% | 17.5% |
| Incorrect, inadequate or imprecise result or readings | 15 | 0.6% | 2.1% |
| Unintended electrical shock | 12 | 0.5% | 0.7% |
| Wireless communication problema wireless connection problem | 10 | 0.4% | 0.9% |
| Overheating of device | 5 | 0.2% | 0.2% |
| High readingsreadings were too high | 2 | 0.1% | 0.7% |
| Low readingsreadings were too low | 2 | 0.1% | 0.6% |
| No audible alarm | 2 | 0.1% | 0.1% |
| Application program freezes or fails to launch | 1 | 0% | 0% |
| Device sensing problem | 1 | 0% | 0.4% |
| Display or visual feedback problem | 1 | 0% | 0.1% |
| Insufficient device problem information | 1 | 0% | 0% |
| Premature end-of-life indicator | 1 | 0% | 0.1% |
| Unable to obtain readings | 1 | 0% | 0.2% |
| Unintended application program shut down | 1 | 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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 391 | 15.6% |
| Painpain, site not specified | 140 | 5.6% |
| Erythemaskin redness | 117 | 4.7% |
| Skin inflammation/ irritation | 81 | 3.2% |
| Bacterial infectiona bacterial infection | 80 | 3.2% |
| Hemorrhage/blood loss/bleeding | 39 | 1.6% |
| Abscessa collection of pus | 36 | 1.4% |
| Rashskin rash | 23 | 0.9% |
| Foreign body reaction | 20 | 0.8% |
| Itching sensation | 19 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 17 | 0.7% |
| Discomfortdiscomfort | 17 | 0.7% |
| Burning sensationa burning feeling | 14 | 0.6% |
| Cellulitisa skin infection | 10 | 0.4% |
| Hypersensitivity/allergic reaction | 10 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Stelo Glucose Biosensor System | Product code SAF | All MAUDE reports |
|---|---|---|---|
| Reports | 2,508 | 2,699 | 26,136,888 |
| Share of that pool | — | 92.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 5.3% | 8.2% | 36.2% |
| Classified as malfunction | 94.7% | 91.6% | 62.3% |
| Filed by the manufacturer | 99.8% | 95.9% | 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 SAF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dexcom G7 Continuous Glucose Monitoring System | 641,507 | 268,781 | 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 Stelo Glucose Biosensor System reports
How many FDA reports name Stelo Glucose Biosensor System?
2,508 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,271 in the latest 12 months.
What kinds of events are reported?
malfunction (94.7%) and injury (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (62.9%), break (18.8%), incorrect, inadequate or imprecise result or readings (0.6%), unintended electrical shock (0.5%) and wireless communication problem (0.4%). 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 Stelo Glucose Biosensor System 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.