Reported Reactions

Devices › Integrated continuous glucose monitoring system, factory calibrated

Device brand name · Continuous glucose monitor

Dexcom G6 Glucose Program Continuous Glucose Monitoring System: medical device reports filed with FDA

5,664 reports name it, 2019–2026. Manufacturer given most often on reports: Dexcom. Product code QBJ.

5,664
device reports naming the brand
0% of all MAUDE reports · about 840 a year
1,759
reports, 12 months to August 2026
3,380 in the 12 months before
99.7%
classified as malfunction
98.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 5,664 reports that name the brand "Dexcom G6 Glucose Program Continuous Glucose Monitoring System" (continuous glucose monitor), received between October 2019 and August 2026; the manufacturer given most often on reports is Dexcom. Spellings of one product vary from report to report.

1,759 reports arrived in the 12 months to August 2026, down 48% from 3,380 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 (99.7%) and injury (0.3%); 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 (59%), no device output (39.4%) and imprecision (0.6%). The patient problems coded most often are hyperglycemia, loss of consciousness and hypoglycemia. 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

0259517Sep 2021: 2Oct 2021: 0Nov 2021: 9Dec 2021: 142022Jan 2022: 2Feb 2022: 1Mar 2022: 8Apr 2022: 1May 2022: 3Jun 2022: 4Jul 2022: 3Aug 2022: 0Sep 2022: 2Oct 2022: 2Nov 2022: 2Dec 2022: 02023Jan 2023: 0Feb 2023: 4Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 2Jul 2023: 1Aug 2023: 1Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 1May 2024: 0Jun 2024: 0Jul 2024: 5Aug 2024: 405Sep 2024: 517Oct 2024: 186Nov 2024: 178Dec 2024: 3452025Jan 2025: 372Feb 2025: 148Mar 2025: 175Apr 2025: 265May 2025: 256Jun 2025: 260Jul 2025: 360Aug 2025: 318Sep 2025: 395Oct 2025: 320Nov 2025: 152Dec 2025: 792026Jan 2026: 67Feb 2026: 49Mar 2026: 99Apr 2026: 84May 2026: 76Jun 2026: 143Jul 2026: 177Aug 2026: 118

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

01,5503,1002019: 1920192020: 1320202021: 4520212022: 2820222023: 920232024: 1,63720242025: 3,10020252026: 8132026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.3%16
Malfunction99.7%5,648
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%5,664
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Wireless communication problema wireless connection problem3,34059%35.7%
No device output2,23039.4%13.2%
Imprecision330.6%4.9%
Premature end-of-life indicator190.3%4.7%
Unintended application program shut down110.2%3.1%
Incorrect, inadequate or imprecise result or readings30.1%10.4%
Low readingsreadings were too low30.1%7.1%
Breakthe device broke20%1.1%
Detachment of device or device componentpart of the device came off20%5.8%
Inappropriate or unexpected reset20%1%
No audible alarm20%0.7%
Operating system version or upgrade problem20%0.4%
Application program freezes or fails to launch10%0.2%
Defective alarm10%0.7%
Display or visual feedback problem10%0.5%
High readingsreadings were too high10%0.7%
Unexpected shutdown10%0.8%
Unintended electrical shock10%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)ReportsShare
Hyperglycemiahigh blood sugar110.2%
Loss of consciousnesspassing out70.1%
Hypoglycemialow blood sugar40.1%
Malaisegeneral feeling of being unwell40.1%
Diaphoresis30.1%
Foreign body in patientpart of a device left in the patient30.1%
Confusion/ disorientation20%
Convulsion/seizure20%
Elevated ketones/ diabetic ketoacidosis20%
Falla fall20%
Fatiguetiredness20%
Headachehead pain20%
Lethargysluggishness20%
Abdominal painstomach or belly pain10%
Blurred vision10%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureDexcom G6 Glucose Program Continuous Glucose Monitoring SystemProduct code QBJAll MAUDE reports
Reports5,6642,268,32526,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports009
Classified as injury0.3%1.9%36.2%
Classified as malfunction99.7%98.1%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Dexcom G6 Continuous Glucose Monitoring System1,339,56261,7100%
Dexcom G7 Continuous Glucose Monitoring System641,507268,7810%
FreeStyle Libre 3120,677103,0450%
FreeStyle Libre 3 Plus91,34888,3230%
FreeStyle Libre 2 Plus49,66845,8390%
Dexcom G7 15 Day Continuous Glucose Monitoring System13,86913,8690%
Libre 3 Sensor FreeStyle12,82920%
FreeStyle Libre 2 Plus Sensor3,9292,7990%
Dexcom G6 Mobile Continuous Glucose Monitoring System1,83300%
Dexcom ONE Continuous Glucose Monitoring System1,5501890%
Dexcom G71,3945830.1%
Libre 2 Plus Sensor FreeStyle808100%
Libre 3 Plus Sensor Freestyle585130%
Dexcom G7 Sensor4361370.2%
Dexcom G6512390.2%

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 G6 Glucose Program Continuous Glucose Monitoring System reports

How many FDA reports name Dexcom G6 Glucose Program Continuous Glucose Monitoring System?

5,664 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,759 in the latest 12 months.

What kinds of events are reported?

malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

wireless communication problem (59%), no device output (39.4%), imprecision (0.6%), premature end-of-life indicator (0.3%) and unintended application program shut down (0.2%). 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 G6 Glucose Program 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.