Devices › Sensor, glucose, invasive
Device brand name · Cgm
Sensor: medical device reports filed with FDA
1,053 reports name it, 2013–2026. Manufacturer given most often on reports: Medtronic Minimed. Product code MDS.
- 1,053
- device reports naming the brand
- 0% of all MAUDE reports · about 78 a year
- 50
- reports, 12 months to August 2026
- 38 in the 12 months before
- 59.7%
- classified as malfunction
- 94.9% across the product code
- 0.3%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 1,053 reports that name the brand "Sensor" (cgm), received between January 2013 and August 2026; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.
50 reports arrived in the 12 months to August 2026, up 32% from 38 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 (59.7%), injury (39.6%) and death (0.3%); across all sensor, glucose, invasive reports (product code MDS) death is recorded in 0.1% and malfunction in 94.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (19.7%), detachment of device or device component (10.9%) and break (10.6%). The patient problems coded most often are hyperglycemia, hypoglycemia and hemorrhage/blood loss/bleeding. 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 282,102 reports carrying product code MDS. 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 |
|---|---|---|---|
| Device displays incorrect message | 207 | 19.7% | 20.4% |
| Detachment of device or device componentpart of the device came off | 115 | 10.9% | 0.1% |
| Breakthe device broke | 112 | 10.6% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 92 | 8.7% | 28.7% |
| Incorrect, inadequate or imprecise result or readings | 81 | 7.7% | 0.6% |
| Incorrect or inadequate test results | 73 | 6.9% | 0.2% |
| Bent | 49 | 4.7% | 0.2% |
| Detachment of device component | 49 | 4.7% | 1.1% |
| Calibration error | 39 | 3.7% | 0% |
| Peeled/delaminated | 38 | 3.6% | 0% |
| Insufficient device problem information | 36 | 3.4% | 0.8% |
| False reading from device non-compliance | 27 | 2.6% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 26 | 2.5% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 25 | 2.4% | 2.7% |
| Device sensing problem | 22 | 2.1% | 0% |
| Device alarm system | 18 | 1.7% | 0.2% |
| Difficult to removethe device was hard to remove | 18 | 1.7% | 0% |
| Low readingsreadings were too low | 16 | 1.5% | 0% |
| Calibration problem | 15 | 1.4% | 0.3% |
| Device expiration issue | 15 | 1.4% | 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 |
|---|---|---|
| Hyperglycemiahigh blood sugar | 295 | 28% |
| Hypoglycemialow blood sugar | 211 | 20% |
| Hemorrhage/blood loss/bleeding | 25 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 22 | 2.1% |
| Rashskin rash | 22 | 2.1% |
| Painpain, site not specified | 18 | 1.7% |
| Caustic/chemical burns | 12 | 1.1% |
| Elevated ketones/ diabetic ketoacidosis | 10 | 0.9% |
| Erythemaskin redness | 10 | 0.9% |
| Itching sensation | 10 | 0.9% |
| Device embedded in tissue or plaque | 8 | 0.8% |
| Loss of consciousnesspassing out | 7 | 0.7% |
| Scar tissue | 7 | 0.7% |
| Skin irritationirritated skin | 7 | 0.7% |
| Bruise/contusion | 5 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sensor | Product code MDS | All MAUDE reports |
|---|---|---|---|
| Reports | 1,053 | 282,102 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 3 | 1 | 9 |
| Classified as injury | 39.6% | 4.8% | 36.2% |
| Classified as malfunction | 59.7% | 94.9% | 62.3% |
| Filed by the manufacturer | 91% | 99.6% | 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 MDS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dexcom G5 Mobile Continuous Glucose Monitoring System | 332,492 | 6 | 0% |
| Dexcom G4 Platinum Continuous Glucose Monitoring System | 53,681 | 0 | 0.1% |
| G4 Platinum Continuous Glucose Monitoring System | 48,906 | 0 | 0.1% |
| Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Share System | 17,717 | 0 | 0.1% |
| Xmtr MMT-7811NA GST3C Lockout | 17,012 | 65 | 0% |
| Animas Vibe | 88,703 | 0 | 0% |
| Paradigm Real-Time Insulin Infusion Pump | 126,282 | 0 | 0.3% |
| Unknown XMTR | 4,431 | 2,027 | 0% |
| Carelink Personal Mmt-7333 | 3,680 | 233 | 0% |
| Guardian Link 3 OUS | 6,663 | 733 | 0% |
| Ni | 32,939 | 1,587 | 1.8% |
| Dexcom G4 Platinum Continuous Monitoring System Dexcom Share System | 2,293 | 0 | 0.3% |
| Paradigm Real-Time Revel Insulin Infusion Pump | 178,691 | 0 | 0.6% |
| Transmitter Mmt-7841zw Gst5g Ous | 31,572 | 12,351 | 0% |
| Xmtr Mmt-7821lna Gst4c Replacement | 1,685 | 13 | 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 Sensor reports
How many FDA reports name Sensor?
1,053 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
malfunction (59.7%), injury (39.6%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (19.7%), detachment of device or device component (10.9%), break (10.6%), device operates differently than expected (8.7%) and incorrect, inadequate or imprecise result or readings (7.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (91%) and voluntary reports (7.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that 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.