Device manufacturer, as written on reports

Dexcom: medical device reports filed with FDA

2,505,798 reports name it as the manufacturer of the device involved, 2009–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,505,798
reports naming it as manufacturer: 9.6% of all MAUDE reports; 348,790
reports, 12 months to August 2026: 362,369 in the 12 months before; 98.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

2,505,798 medical device reports received by FDA give Dexcom as the manufacturer of the device involved, 9.6% of the MAUDE database, from April 2009 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

348,790 reports arrived in the 12 months to August 2026, close to the 362,369 of 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 (98.7%) and injury (1.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Dexcom G6 Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	1,339,044	61,710	0%
Dexcom G7 Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	641,326	268,781	0%
Dexcom G5 Mobile Continuous Glucose Monitoring System	Sensor, glucose, invasive, non-adjunctive	332,483	6	0%
Dexcom G4 Platinum Continuous Glucose Monitoring System	Sensor, glucose, invasive	53,598	0	0.1%
G4 Platinum Continuous Glucose Monitoring System	Sensor, glucose, invasive	48,886	0	0.1%
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Share System	Sensor, glucose, invasive	17,717	0	0.1%
Dexcom G7 15 Day Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	13,821	13,869	0%
T Slim G5 System	Pump, infusion, insulin, to be used with invasive glucose sensor	13,533	0	0%
Dexcom G6 Glucose Program Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	5,664	1,759	0%
t:slim G4 system	Pump, infusion, insulin, to be used with invasive glucose sensor	3,784	20	0%
Animas Vibe System	Pump, infusion, insulin, to be used with invasive glucose sensor	3,076	0	0.1%
Ni	Set, administration, for peritoneal dialysis, disposable	2,826	1,587	1.8%
Stelo Glucose Biosensor System	Integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter	2,507	1,271	0%
Animas Vibe	Pump, infusion, insulin, to be used with invasive glucose sensor	2,411	0	0%
Dexcom G4 Platinum Continuous Monitoring System Dexcom Share System	Sensor, glucose, invasive	2,293	0	0.3%
Dexcom G6 Mobile Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	1,833	0	0%
Dexcom ONE Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	1,548	189	0%
Dexcom G4 Platinum Professional Continuous Glucose Monitoring System	Sensor, glucose, invasive	1,457	0	0%
Dexcom G7	Integrated continuous glucose monitoring system, factory calibrated	1,388	583	0.1%
G4 Platinum Pediatric Continuous Glucose Monitoring System	Sensor, glucose, invasive	1,334	0	0%
Dexcom G4 Platinum Pediatric Continuous Glucose Monitoring System	Sensor, glucose, invasive	1,072	0	0%
G4 Platinum Continuous Glucose Monitors	Sensor, glucose, invasive	1,049	0	0%
Seven Continuous Glucose Monitoring Sensor	Sensor, glucose, invasive	775	0	0.5%
G4 Platinum Continuous Glucose Monotoring Sytem	Sensor, glucose, invasive	708	0	0%
Dexcom G5 Platinum Continuous Glucose Monitoring System	Sensor, glucose, invasive	519	0	0%
Dexcom G6	Integrated continuous glucose monitoring system, factory calibrated	512	39	0.2%
G4platnium Continuous Glucose Monitoring System	Sensor, glucose, invasive	509	0	0%
Dexcom G5 Mobile Continuous Glucose Monitoring	Sensor, glucose, invasive, non-adjunctive	490	0	0%
Dexcom G7 Sensor	Integrated continuous glucose monitoring system, factory calibrated	432	137	0.2%
G4 Platinum Glucose Continuous Monitoring System	Sensor, glucose, invasive	402	0	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
QBJ	Integrated continuous glucose monitoring system, factory calibrated	2,007,288	80.1%
PQF	Sensor, glucose, invasive, non-adjunctive	242,852	9.7%
MDS	Sensor, glucose, invasive	229,705	9.2%
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	22,900	0.9%
SAF	Integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter	2,595	0.1%
QDK	Integrated continuous glucose monitoring system for non-intensive diabetes management	627	0%
OZO	Automated insulin dosing , threshold suspend	253	0%
OBJ	Catheter, ultrasound, intravascular	52	0%
LZG	Pump, infusion, insulin	25	0%
QFG	Alternate controller enabled insulin infusion pump	18	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%355

Injury1.3%32,847

Malfunction98.7%2,471,985

Other0%554

Not given0%57

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Dexcom reports

How many FDA device reports name Dexcom as manufacturer?

2,505,798 reports through August 2026, 348,790 of them in the latest 12 months.

Which of its brands appear most often?

Dexcom G6 Continuous Glucose Monitoring System (1,339,044), Dexcom G7 Continuous Glucose Monitoring System (641,326), Dexcom G5 Mobile Continuous Glucose Monitoring System (332,483), Dexcom G4 Platinum Continuous Glucose Monitoring System (53,598) and G4 Platinum Continuous Glucose Monitoring System (48,886).

Which device types does it report on?

integrated continuous glucose monitoring system, factory calibrated (80.1%), sensor, glucose, invasive, non-adjunctive (9.7%), sensor, glucose, invasive (9.2%) and pump, infusion, insulin, to be used with invasive glucose sensor (0.9%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.