Devices › Sensor, glucose, invasive, non-adjunctive
Device brand name · Continuous glucose monitor
Dexcom G5 Mobile Continuous Glucose Monitoring System: medical device reports filed with FDA
332,492 reports name it, 2015–2026. Manufacturer given most often on reports: Dexcom. Product code PQF.
- 332,492
- device reports naming the brand
- 1.3% of all MAUDE reports · about 30,941 a year
- 6
- reports, 12 months to August 2026
- 10 in the 12 months before
- 99.1%
- classified as malfunction
- 99.3% across the product code
- 0%
- classified as death, as reported
- 25 reports · not verified by FDA
FDA's MAUDE database holds 332,492 reports that name the brand "Dexcom G5 Mobile Continuous Glucose Monitoring System" (continuous glucose monitor), received between October 2015 and July 2026; the manufacturer given most often on reports is Dexcom. Spellings of one product vary from report to report.
6 reports arrived in the 12 months to August 2026, down 40% from 10 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 (99.1%) and injury (0.9%); across all sensor, glucose, invasive, non-adjunctive reports (product code PQF) death is recorded in 0% and malfunction in 99.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are wireless communication problem (35.9%), device displays incorrect message (17.5%) and imprecision (15.4%). The patient problems coded most often are hypoglycemia, reaction 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 325,941 reports carrying product code PQF. 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 | 119,391 | 35.9% | 52.3% |
| Device displays incorrect message | 58,202 | 17.5% | 8.6% |
| Imprecision | 51,356 | 15.4% | 15.8% |
| No device output | 25,116 | 7.6% | 7.7% |
| Invalid sensing | 22,862 | 6.9% | 2.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 12,607 | 3.8% | 0.7% |
| Defective alarm | 5,827 | 1.8% | 1.2% |
| Device inoperablethe device could not be used | 5,060 | 1.5% | 1.2% |
| Inappropriate or unexpected reset | 5,015 | 1.5% | 1.1% |
| Premature end-of-life indicator | 4,962 | 1.5% | 1.5% |
| Unable to obtain readings | 4,084 | 1.2% | 1.3% |
| No audible alarm | 3,458 | 1% | 0.3% |
| Detachment of device or device componentpart of the device came off | 2,971 | 0.9% | 0.9% |
| Unexpected shutdown | 2,840 | 0.9% | 0.9% |
| Low battery | 2,005 | 0.6% | 0.6% |
| Component missing | 1,884 | 0.6% | 0.4% |
| Connection problema connection problem | 1,649 | 0.5% | 0.5% |
| Detachment of device component | 1,535 | 0.5% | 0.3% |
| Unintended application program shut down | 1,310 | 0.4% | 0.4% |
| Display or visual feedback problem | 1,038 | 0.3% | 1.3% |
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 |
|---|---|---|
| Hypoglycemialow blood sugar | 1,229 | 0.4% |
| Reactiona reaction, type not specified | 734 | 0.2% |
| Erythemaskin redness | 568 | 0.2% |
| Loss of consciousnesspassing out | 519 | 0.2% |
| Itching sensation | 397 | 0.1% |
| Rashskin rash | 234 | 0.1% |
| Hyperglycemiahigh blood sugar | 211 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 172 | 0.1% |
| Seizures | 165 | 0% |
| Skin irritationirritated skin | 158 | 0% |
| Painpain, site not specified | 147 | 0% |
| Scarring | 144 | 0% |
| Elevated ketones/ diabetic ketoacidosis | 116 | 0% |
| Purulent discharge | 109 | 0% |
| Confusion/ disorientation | 107 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dexcom G5 Mobile Continuous Glucose Monitoring System | Product code PQF | All MAUDE reports |
|---|---|---|---|
| Reports | 332,492 | 325,941 | 26,136,888 |
| Share of that pool | — | 102% | 1.3% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.9% | 0.7% | 36.2% |
| Classified as malfunction | 99.1% | 99.3% | 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 PQF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Transmitter Mmt-7841zn Gst5g Us | 42,013 | 14,186 | 0% |
| Transmitter Mmt-7841zw Gst5g Ous | 31,572 | 12,351 | 0% |
| Sensor Mmt-5120c Instinct 780 5pk Ous 1 | 2,942 | 1,681 | 0% |
| Sensor Mmt-5120d1 Instinct 780 1pk Ous 1 | 2,830 | 1,753 | 0% |
| Transmitter Mmt-7841qzw Gst5g Ous Lckout | 1,632 | 187 | 0% |
| Sensor Mmt-5100jd1 Simplera 1pk Ous1 | 1,356 | 775 | 0% |
| Sensor Mmt-5100jc1 Simplera 5pk Ous1 | 1,107 | 713 | 0% |
| Sensor Mmt-5120d2 Instinct 780 1pk Ous 2 | 1,787 | 1,062 | 0% |
| Dexcom G6 Continuous Glucose Monitoring System | 1,339,562 | 61,710 | 0% |
| Dexcom G5 Mobile Continuous Glucose Monitoring | 490 | 0 | 0% |
| Sensor Mmt-5100jd2 Simplera 1pk Ous2 | 369 | 239 | 0% |
| Sensor Mmt-5100jd3 Simplera 1pk Ous3 | 322 | 196 | 0% |
| SFTWR MMT-8400 CGM Module iOS | 310 | 137 | 0% |
| Xmtr Kit Mmt-7840w1 Grdn 4 9l W | 293 | 180 | 0% |
| Sensor Mmt-5120c2 Instinct 780 5pk Ous 2 | 340 | 133 | 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 G5 Mobile Continuous Glucose Monitoring System reports
How many FDA reports name Dexcom G5 Mobile Continuous Glucose Monitoring System?
332,492 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
malfunction (99.1%) and injury (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
wireless communication problem (35.9%), device displays incorrect message (17.5%), imprecision (15.4%), no device output (7.6%) and invalid sensing (6.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Dexcom G5 Mobile 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.