Devices › Integrated continuous glucose monitoring system, factory calibrated
Device brand name · Continuous glucose monitor
Dexcom ONE Continuous Glucose Monitoring System: medical device reports filed with FDA
1,550 reports name it, 2021–2026. Manufacturer given most often on reports: Dexcom. Product code QBJ.
- 1,550
- device reports naming the brand
- 0% of all MAUDE reports · about 327 a year
- 189
- reports, 12 months to August 2026
- 259 in the 12 months before
- 99.5%
- classified as malfunction
- 98.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,550 medical device reports received by FDA name the brand "Dexcom ONE Continuous Glucose Monitoring System" (continuous glucose monitor); the manufacturer given most often on reports is Dexcom; received from October 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
189 reports arrived in the 12 months to August 2026, down 27% from 259 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 (99.5%) and injury (0.5%); across all integrated continuous glucose monitoring system, factory calibrated reports (product code QBJ) death is recorded in 0% and malfunction in 98.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are wireless communication problem (52.5%), no device output (7.1%) and unintended application program shut down (6.9%). The patient problems coded most often are hyperglycemia, hypoglycemia and foreign body in patient. 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 2,268,325 reports carrying product code QBJ. 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 |
|---|---|---|---|
| Wireless communication problema wireless connection problem | 814 | 52.5% | 35.7% |
| No device output | 110 | 7.1% | 13.2% |
| Unintended application program shut down | 107 | 6.9% | 3.1% |
| Premature end-of-life indicator | 83 | 5.4% | 4.7% |
| Incorrect, inadequate or imprecise result or readings | 77 | 5% | 10.4% |
| Imprecision | 70 | 4.5% | 4.9% |
| Detachment of device or device componentpart of the device came off | 62 | 4% | 5.8% |
| No audible alarm | 43 | 2.8% | 0.7% |
| Low readingsreadings were too low | 27 | 1.7% | 7.1% |
| Defective alarm | 25 | 1.6% | 0.7% |
| Operating system version or upgrade problem | 22 | 1.4% | 0.4% |
| Application program freezes or fails to launch | 20 | 1.3% | 0.2% |
| Breakthe device broke | 18 | 1.2% | 1.1% |
| Display or visual feedback problem | 14 | 0.9% | 0.5% |
| Inappropriate or unexpected reset | 13 | 0.8% | 1% |
| High readingsreadings were too high | 8 | 0.5% | 0.7% |
| Connection problema connection problem | 6 | 0.4% | 0.4% |
| Unable to obtain readings | 4 | 0.3% | 0.6% |
| Low audible alarm | 3 | 0.2% | 0.1% |
| Unexpected shutdown | 2 | 0.1% | 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 |
|---|---|---|
| Hyperglycemiahigh blood sugar | 89 | 5.7% |
| Hypoglycemialow blood sugar | 27 | 1.7% |
| Foreign body in patientpart of a device left in the patient | 12 | 0.8% |
| Loss of consciousnesspassing out | 5 | 0.3% |
| Fatiguetiredness | 3 | 0.2% |
| Confusion/ disorientation | 2 | 0.1% |
| Convulsion/seizure | 2 | 0.1% |
| Erythemaskin redness | 2 | 0.1% |
| Falla fall | 2 | 0.1% |
| Bruise/contusion | 1 | 0.1% |
| Coma | 1 | 0.1% |
| Diaphoresis | 1 | 0.1% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.1% |
| Emotional changes | 1 | 0.1% |
| Hemorrhage/blood loss/bleeding | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dexcom ONE Continuous Glucose Monitoring System | Product code QBJ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,550 | 2,268,325 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 1.9% | 36.2% |
| Classified as malfunction | 99.5% | 98.1% | 62.3% |
| Filed by the manufacturer | 100% | 99.7% | 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 QBJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitoring System | 1,339,562 | 61,710 | 0% |
| Dexcom G7 Continuous Glucose Monitoring System | 641,507 | 268,781 | 0% |
| FreeStyle Libre 3 | 120,677 | 103,045 | 0% |
| FreeStyle Libre 3 Plus | 91,348 | 88,323 | 0% |
| FreeStyle Libre 2 Plus | 49,668 | 45,839 | 0% |
| Dexcom G7 15 Day Continuous Glucose Monitoring System | 13,869 | 13,869 | 0% |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring System | 5,664 | 1,759 | 0% |
| Libre 3 Sensor FreeStyle | 12,829 | 2 | 0% |
| FreeStyle Libre 2 Plus Sensor | 3,929 | 2,799 | 0% |
| Dexcom G6 Mobile Continuous Glucose Monitoring System | 1,833 | 0 | 0% |
| Dexcom G7 | 1,394 | 583 | 0.1% |
| Libre 2 Plus Sensor FreeStyle | 808 | 10 | 0% |
| Libre 3 Plus Sensor Freestyle | 585 | 13 | 0% |
| Dexcom G7 Sensor | 436 | 137 | 0.2% |
| Dexcom G6 | 512 | 39 | 0.2% |
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 Dexcom ONE Continuous Glucose Monitoring System reports
How many FDA reports name Dexcom ONE Continuous Glucose Monitoring System?
1,550 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 189 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
wireless communication problem (52.5%), no device output (7.1%), unintended application program shut down (6.9%), premature end-of-life indicator (5.4%) and incorrect, inadequate or imprecise result or readings (5%). 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 Dexcom ONE Continuous Glucose Monitoring 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.