Sensor, glucose, invasive: medical device reports filed with FDA

282,102 reports carry this product code, 1992–2026; 30 brands with a page.

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.

282,102
reports with this product code: 1.1% of all MAUDE reports; 2,992
reports, 12 months to August 2026: 2,261 in the 12 months before; 94.9%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code MDS is FDA's classification for "Sensor, glucose, invasive" (unknown panel), a class 3 device. 282,102 medical device reports carry this product code, 1.1% of the MAUDE database, from March 1992 to August 2026.

2,992 reports arrived in the 12 months to August 2026, up 32% from 2,261 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 (94.9%), injury (4.8%) and other (0.1%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Dexcom G5 Mobile Continuous Glucose Monitoring System	91,756	6	0%	99.1%
Dexcom G4 Platinum Continuous Glucose Monitoring System	53,431	0	0.1%	97.2%
G4 Platinum Continuous Glucose Monitoring System	48,906	0	0.1%	98.3%
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Share System	17,706	0	0.1%	98.6%
Xmtr MMT-7811NA GST3C Lockout	5,547	65	0%	99.5%
Animas Vibe	4,700	0	0%	98%
Paradigm Real-Time Insulin Infusion Pump	4,670	0	0.3%	87.9%
Unknown XMTR	4,429	2,027	0%	99.5%
Carelink Personal Mmt-7333	3,055	233	0%	99.7%
Guardian Link 3 OUS	2,500	733	0%	99.8%
Ni	2,346	1,587	1.8%	29.5%
Dexcom G4 Platinum Continuous Monitoring System Dexcom Share System	2,293	0	0.3%	97.9%
Paradigm Real-Time Revel Insulin Infusion Pump	2,111	0	0.6%	64%
Transmitter Mmt-7841zw Gst5g Ous	1,748	12,351	0%	99.8%
Xmtr Mmt-7821lna Gst4c Replacement	1,685	13	0%	99.6%
Gst4c Ous	1,637	2	0%	100%
Dexcom G4 Platinum Professional Continuous Glucose Monitoring System	1,453	0	0%	100%
G4 Platinum Pediatric Continuous Glucose Monitoring System	1,334	0	0%	99.6%
Transmitter Mmt-7731 Gst3b Replacement	1,147	0	0%	100%
Dexcom G4 Platinum Pediatric Continuous Glucose Monitoring System	1,072	0	0%	98.5%
Ot Ping Meter	1,065	0	0%	98.1%
G4 Platinum Continuous Glucose Monitors	1,049	0	0%	99.4%
Guardian Link 3 US	1,039	229	0%	99.3%
Ot Ultralink Meter	1,032	0	0%	96.1%
Software Css7200 Grdn Ios App	952	2	0%	99.5%
Starter Kit Mmt-7821ww Gst4c Ous	876	1	0%	99.8%
Sftwr Css7201 Guardian Android App	796	2	0%	100%
Seven Continuous Glucose Monitoring Sensor	776	0	0.5%	13%
G4 Platinum Continuous Glucose Monotoring Sytem	708	0	0%	91.7%
Sensor	675	50	0.3%	59.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Dexcom	229,705	81.4%
Medtronic Minimed	41,125	14.6%
Animas	4,340	1.5%
Medtronic Puerto Rico Operations Med-Rel	3,552	1.3%
Lifescan	2,128	0.8%
Medtronic Puerto Rico Operations	1,592	0.6%
Abbott Diabetes Care	695	0.2%
Medtronic Puerto Rico Operations Juncos	138	0%
Abbott Diabetes Care USA	36	0%
Abbott Laboratories	11	0%
Mdt Puerto Rico Operations Med Rel	5	0%
Abbott	2	0%
Tandem Diabetes Care	2	0%
Insulet	1	0%
Lifescan Europe	1	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 and report source

Event type

Death0.1%321

Injury4.8%13,641

Malfunction94.9%267,653

Other0.1%419

Not given0%68

Who filed

Manufacturer report99.6%280,903

Voluntary report0.4%1,190

User facility report0%0

Distributor report0%1

Not given0%8

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device operates differently than expectedthe device behaved unexpectedly	81,012	28.7%
Wireless communication problema wireless connection problem	60,190	21.3%
Device displays incorrect message	57,573	20.4%
Invalid sensing	25,600	9.1%
No audible alarm	12,118	4.3%
Communication or transmission problemthe device could not communicate or transmit	7,503	2.7%
Defective alarm	7,029	2.5%
Imprecision	5,653	2%
Battery problema problem with the battery	4,178	1.5%
Computer software problema software problem	3,499	1.2%
Inappropriate or unexpected reset	3,165	1.1%
Device inoperablethe device could not be used	3,121	1.1%
Component missing	2,980	1.1%
Detachment of device component	2,967	1.1%
Breakthe device broke	2,354	0.8%
Insufficient device problem information	2,268	0.8%
Display or visual feedback problem	1,797	0.6%
Incorrect, inadequate or imprecise result or readings	1,625	0.6%
Improper or incorrect procedure or method	1,279	0.5%
Crackthe device cracked	1,227	0.4%

Questions about sensor, glucose, invasive reports

What is product code MDS?

FDA's classification code for "Sensor, glucose, invasive", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

282,102 reports through August 2026, 2,992 of them in the latest 12 months.

Which brands appear most often?

Dexcom G5 Mobile Continuous Glucose Monitoring System (91,756), Dexcom G4 Platinum Continuous Glucose Monitoring System (53,431), G4 Platinum Continuous Glucose Monitoring System (48,906), Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Share System (17,706) and Xmtr MMT-7811NA GST3C Lockout (5,547). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.