Devices › Sensor, glucose, invasive
Device brand name · Mds
Dexcom G4 Platinum Continuous Glucose Monitoring System: medical device reports filed with FDA
53,681 reports name it, 2015–2023. Manufacturer given most often on reports: Dexcom. Product code MDS.
- 53,681
- device reports naming the brand
- 0.2% of all MAUDE reports · about 4,705 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.2%
- classified as malfunction
- 94.9% across the product code
- 0.1%
- classified as death, as reported
- 69 reports · not verified by FDA
53,681 medical device reports received by FDA name the brand "Dexcom G4 Platinum Continuous Glucose Monitoring System" (mds); the manufacturer given most often on reports is Dexcom; received from February 2015 to September 2023. 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 (97.2%), injury (2.6%) and death (0.1%); 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 operates differently than expected (29.3%), device displays incorrect message (17%) and wireless communication problem (15.7%). The patient problems coded most often are erythema, hypoglycemia and reaction. 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 operates differently than expectedthe device behaved unexpectedly | 15,736 | 29.3% | 28.7% |
| Device displays incorrect message | 9,137 | 17% | 20.4% |
| Wireless communication problema wireless connection problem | 8,444 | 15.7% | 21.3% |
| Invalid sensing | 7,596 | 14.2% | 9.1% |
| Imprecision | 4,668 | 8.7% | 2% |
| No audible alarm | 3,304 | 6.2% | 4.3% |
| Defective alarm | 1,403 | 2.6% | 2.5% |
| Detachment of device component | 1,028 | 1.9% | 1.1% |
| Unable to obtain readings | 865 | 1.6% | 0.3% |
| Device inoperablethe device could not be used | 762 | 1.4% | 1.1% |
| Component missing | 664 | 1.2% | 1.1% |
| Unexpected shutdown | 446 | 0.8% | 0.2% |
| Inappropriate or unexpected reset | 404 | 0.8% | 1.1% |
| No device output | 185 | 0.3% | 0.1% |
| Detachment of device or device componentpart of the device came off | 148 | 0.3% | 0.1% |
| Breakthe device broke | 146 | 0.3% | 0.8% |
| Display or visual feedback problem | 135 | 0.3% | 0.6% |
| Incorrect, inadequate or imprecise result or readings | 132 | 0.2% | 0.6% |
| Incorrect or inadequate test results | 112 | 0.2% | 0.2% |
| Overheating of device | 110 | 0.2% | 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 |
|---|---|---|
| Erythemaskin redness | 427 | 0.8% |
| Hypoglycemialow blood sugar | 427 | 0.8% |
| Reactiona reaction, type not specified | 292 | 0.5% |
| Itching sensation | 279 | 0.5% |
| Rashskin rash | 268 | 0.5% |
| Loss of consciousnesspassing out | 175 | 0.3% |
| Skin irritationirritated skin | 159 | 0.3% |
| Purulent discharge | 109 | 0.2% |
| Skin inflammation | 105 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 101 | 0.2% |
| Hyperglycemiahigh blood sugar | 74 | 0.1% |
| Painpain, site not specified | 64 | 0.1% |
| Deaththe patient died; cause not stated by this term | 62 | 0.1% |
| Scarring | 55 | 0.1% |
| Seizures | 54 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dexcom G4 Platinum Continuous Glucose Monitoring System | Product code MDS | All MAUDE reports |
|---|---|---|---|
| Reports | 53,681 | 282,102 | 26,136,888 |
| Share of that pool | — | 19% | 0.2% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 2.6% | 4.8% | 36.2% |
| Classified as malfunction | 97.2% | 94.9% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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% |
| Gst4c Ous | 1,637 | 2 | 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 Dexcom G4 Platinum Continuous Glucose Monitoring System reports
How many FDA reports name Dexcom G4 Platinum Continuous Glucose Monitoring System?
53,681 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 (97.2%), injury (2.6%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (29.3%), device displays incorrect message (17%), wireless communication problem (15.7%), invalid sensing (14.2%) and imprecision (8.7%). 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 G4 Platinum 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.