Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems: medical device reports filed with FDA

213,812 reports carry this product code, 2020–2026; 24 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.

213,812
reports with this product code: 0.8% of all MAUDE reports; 72,863
reports, 12 months to August 2026: 27,993 in the 12 months before; 80.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code QLG is FDA's classification for "Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems" (clinical Chemistry panel), a class 2 device. 213,812 medical device reports carry this product code, 0.8% of the MAUDE database, from September 2020 to August 2026.

72,863 reports arrived in the 12 months to August 2026, up 160% from 27,993 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 (80.3%) and injury (19.7%). 24 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
FreeStyle Libre 2	113,377	67,297	0%	68.2%
Libre 2 Sensor FreeStyle	75,838	3	0%	99.6%
FreeStyle Libre 3	11,723	103,045	0%	90.5%
Libre 3 Sensor FreeStyle	8,901	2	0%	99.3%
Instinct	1,156	1,171	0%	91.7%
FreeStyle Libre Select	1,068	1,063	0%	91.2%
FreeStyle Libre 3 Plus	256	88,323	0%	93.8%
FreeStyle Libre 2 Sensor	141	52	3.1%	73.2%
FreeStyle Libre 2 Plus	98	45,839	0%	91.7%
FreeStyle Libre 3 Sensor	93	74	1.5%	80.2%
Libre 2 Plus Sensor FreeStyle	63	10	0%	98.3%
Fs Opt-No Coding	42	0	0%	100%
FreeStyle LibreLink	35	6,512	0%	86.3%
Freestyle Libre 14 Day	32	10,976	0%	50%
Libre 3 Plus Sensor Freestyle	24	13	0%	98.1%
FreeStyle Libre 2 Plus Sensor	22	2,799	0%	99.9%
Libre Sensor Freestyle	22	12	0%	100%
FreeStyle Libre	20	1,560	0%	50%
Freestyle Libre 3 Plus Sensor	5	96	2.5%	77.9%
FreeStyle Libre Sensor 14 Day	4	117	0%	99.6%
FreeStyle Neo	3	2,200	0%	99.8%
Dexcom G6	2	39	0.2%	23%
Dexcom G7	2	583	0.1%	51.6%
FreeStyle Libre Sensor	2	11	0%	95.6%

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
Abbott Diabetes Care	213,789	100%
Dexcom	4	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%30

Injury19.7%42,056

Malfunction80.3%171,704

Other0%21

Not given0%1

Who filed

Manufacturer report99.8%213,443

Voluntary report0.2%369

User facility report0%0

Distributor report0%0

Not given0%0

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect, inadequate or imprecise result or readings	157,887	73.8%
Unable to obtain readings	18,375	8.6%
Device displays incorrect message	18,038	8.4%
Device alarm system	12,111	5.7%
Low readingsreadings were too low	6,125	2.9%
High readingsreadings were too high	5,310	2.5%
Detachment of device or device componentpart of the device came off	4,504	2.1%
Product quality problem	3,963	1.9%
Failure to power up	973	0.5%
Application program problem	525	0.2%
Premature discharge of battery	250	0.1%
Failure to fire	155	0.1%
Activation, positioning or separation problem	148	0.1%
Material twisted/bent	140	0.1%
No device output	133	0.1%
No audible alarm	130	0.1%
Unintended electrical shock	116	0.1%
Power problem	99	0%
Difficult to insertthe device was hard to insert	66	0%
Display or visual feedback problem	58	0%

Questions about integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems reports

What is product code QLG?

FDA's classification code for "Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems", class 2, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.

How many reports carry this code?

213,812 reports through August 2026, 72,863 of them in the latest 12 months.

Which brands appear most often?

FreeStyle Libre 2 (113,377), Libre 2 Sensor FreeStyle (75,838), FreeStyle Libre 3 (11,723), Libre 3 Sensor FreeStyle (8,901) and Instinct (1,156). 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.