Dexcom G5 Mobile Continuous Glucose Monitoring: medical device reports filed with FDA

490 reports name it, 2015–2018. Manufacturer given most often on reports: Dexcom. Product code PQF.

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.

490
device reports naming the brand: 0% of all MAUDE reports · about 46 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 100%
classified as malfunction: 99.3% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 490 reports that name the brand "Dexcom G5 Mobile Continuous Glucose Monitoring" (continuous glucose monitor), received between December 2015 and July 2018; the manufacturer given most often on reports is Dexcom. Spellings of one product vary from report to report.

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 (100%); 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 (89.2%), inappropriate or unexpected reset (5.7%) and device inoperable (1%). 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

No report naming Dexcom G5 Mobile Continuous Glucose Monitoring was received in the five years to August 2026; the latest was received in July 2018.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%490

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%490

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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	437	89.2%	52.3%
Inappropriate or unexpected reset	28	5.7%	1.1%
Device inoperablethe device could not be used	5	1%	1.2%
Device operates differently than expectedthe device behaved unexpectedly	3	0.6%	0.7%
Invalid sensing	1	0.2%	2.1%
No audible alarm	1	0.2%	0.3%

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.

In context

Measure	Dexcom G5 Mobile Continuous Glucose Monitoring	Product code PQF	All MAUDE reports
Reports	490	325,941	26,136,888
Share of that pool	—	0.2%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0%	0.7%	36.2%
Classified as malfunction	100%	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
Dexcom G5 Mobile Continuous Glucose Monitoring System	332,492	6	0%
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%
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 reports

How many FDA reports name Dexcom G5 Mobile Continuous Glucose Monitoring?

490 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

wireless communication problem (89.2%), inappropriate or unexpected reset (5.7%), device inoperable (1%), device operates differently than expected (0.6%) and invalid sensing (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 G5 Mobile Continuous Glucose Monitoring 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.