Device manufacturer, as written on reports

Abbott Diabetes Care: medical device reports filed with FDA

682,164 reports name it as the manufacturer of the device involved, 2005–2026.

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.

682,164
reports naming it as manufacturer: 2.6% of all MAUDE reports; 334,008
reports, 12 months to August 2026: 52,242 in the 12 months before; 88.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

682,164 medical device reports received by FDA give Abbott Diabetes Care as the manufacturer of the device involved, 2.6% of the MAUDE database, from February 2005 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

334,008 reports arrived in the 12 months to August 2026, up 539% from 52,242 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 (88.3%) and injury (11.6%). 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
FreeStyle Libre 3	Integrated continuous glucose monitoring system, factory calibrated	120,645	103,045	0%
FreeStyle Libre 2	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	113,649	67,297	0%
FreeStyle Libre 3 Plus	Integrated continuous glucose monitoring system, factory calibrated	91,336	88,323	0%
Libre Sensor Freestyle	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	77,776	12	0%
Libre 2 Sensor FreeStyle	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	76,419	3	0%
FreeStyle Libre 2 Plus	Integrated continuous glucose monitoring system, factory calibrated	49,668	45,839	0%
Freestyle Libre 14 Day	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	25,861	10,976	0%
FreeStyle Libre Sensor 14 Day	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	13,296	117	0%
Libre 3 Sensor FreeStyle	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	12,816	2	0%
Neo Meter Optium FreeStyle	System, test, blood glucose, over the counter	10,691	132	0%
FreeStyle Precision Neo	System, test, blood glucose, over the counter	10,401	35	0%
FreeStyle Lite	System, test, blood glucose, over the counter	9,776	430	0%
FreeStyle Freedom Lite	System, test, blood glucose, over the counter	9,624	694	0%
FreeStyle LibreLink	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	8,145	6,512	0%
Precision Xtra	System, test, blood glucose, over the counter	7,053	6	0.1%
FreeStyle Libre	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	6,037	1,560	0%
Freedom Lite Meter FreeStyle	System, test, blood glucose, over the counter	4,274	29	0%
FreeStyle Libre 2 Plus Sensor	Integrated continuous glucose monitoring system, factory calibrated	3,929	2,799	0%
Freestyle Flash	Glucose dehydrogenase, glucose	3,206	0	0%
Lite Meter FreeStyle	System, test, blood glucose, over the counter	3,132	31	0%
FreeStyle Neo	System, test, blood glucose, over the counter	2,894	2,200	0%
FreeStyle Insulinx	System, test, blood glucose, over the counter	2,295	16	0%
Freestyle Freedom	System, test, blood glucose, over the counter	2,130	6	0%
Freestyle	Glucose dehydrogenase, glucose	1,629	26	0.1%
Neo Meter Precision FreeStyle	System, test, blood glucose, over the counter	1,425	26	0%
Instinct	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	1,161	1,171	0%
FreeStyle Libre Select	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	1,068	1,063	0%
Optium Xceed Meter	System, test, blood glucose, over the counter	935	9	0%
Libre 2 Plus Sensor FreeStyle	Integrated continuous glucose monitoring system, factory calibrated	803	10	0%
FreeStyle Libre Sensor	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	771	11	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	260,623	38.2%
QLG	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	213,789	31.3%
PZE	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated	133,514	19.6%
NBW	System, test, blood glucose, over the counter	69,001	10.1%
LFR	Glucose dehydrogenase, glucose	5,044	0.7%
MDS	Sensor, glucose, invasive	695	0.1%
SAF	Integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter	101	0%
FMK	Single use only blood lancet with an integral sharps injury prevention feature	82	0%
CGA	Glucose oxidase, glucose	26	0%
CFR	Hexokinase, glucose	10	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%159

Injury11.6%79,266

Malfunction88.3%602,608

Other0%101

Not given0%30

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

Questions about Abbott Diabetes Care reports

How many FDA device reports name Abbott Diabetes Care as manufacturer?

682,164 reports through August 2026, 334,008 of them in the latest 12 months.

Which of its brands appear most often?

FreeStyle Libre 3 (120,645), FreeStyle Libre 2 (113,649), FreeStyle Libre 3 Plus (91,336), Libre Sensor Freestyle (77,776) and Libre 2 Sensor FreeStyle (76,419).

Which device types does it report on?

integrated continuous glucose monitoring system, factory calibrated (38.2%), integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems (31.3%), sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated (19.6%) and system, test, blood glucose, over the counter (10.1%).

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.