Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated: medical device reports filed with FDA

133,421 reports carry this product code, 2017–2026; 19 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.

133,421
reports with this product code: 0.5% of all MAUDE reports; 19,450
reports, 12 months to August 2026: 2,503 in the 12 months before; 86.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code PZE is FDA's classification for "Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated" (unknown panel), a class 3 device. 133,421 medical device reports carry this product code, 0.5% of the MAUDE database, from December 2017 to August 2026.

19,450 reports arrived in the 12 months to August 2026, up 677% from 2,503 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 (86.9%) and injury (13.1%). 19 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
Libre Sensor Freestyle	77,759	12	0%	100%
Freestyle Libre 14 Day	25,815	10,976	0%	50%
FreeStyle Libre Sensor 14 Day	13,292	117	0%	99.6%
FreeStyle LibreLink	8,108	6,512	0%	86.3%
FreeStyle Libre	5,957	1,560	0%	50%
FreeStyle Libre Sensor	765	11	0%	95.6%
Libre 2 Sensor FreeStyle	568	3	0%	99.6%
FreeStyle Libre App	156	156	0%	98.1%
FreeStyle Libre 2	137	67,297	0%	68.2%
Fs Opt-No Coding	98	0	0%	100%
FreeStyle Libre 2 Plus	37	45,839	0%	91.7%
FreeStyle Libre 2 Sensor	17	52	3.1%	73.2%
Libre 3 Sensor FreeStyle	4	2	0%	99.3%
FreeStyle Libre 3 Plus	2	88,323	0%	93.8%
Freestyle	1	26	0.1%	85.8%
Freestyle Freedom	1	6	0%	84.3%
Freestyle Libre 3 Plus Sensor	1	96	2.5%	77.9%
Neo Meter Optium FreeStyle	1	132	0%	99.9%
Neo Meter Precision FreeStyle	1	26	0%	99.9%

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	133,514	100.1%
Dexcom	2	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%13

Injury13.1%17,459

Malfunction86.9%115,941

Other0%4

Not given0%4

Who filed

Manufacturer report99.8%133,174

Voluntary report0.2%247

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	107,020	80.2%
Device alarm system	7,527	5.6%
Device displays incorrect message	4,088	3.1%
Unable to obtain readings	3,838	2.9%
High readingsreadings were too high	3,255	2.4%
Low readingsreadings were too low	2,770	2.1%
Application program problem	1,438	1.1%
Detachment of device or device componentpart of the device came off	1,202	0.9%
Product quality problem	1,016	0.8%
Failure to power up	311	0.2%
No device output	122	0.1%
Failure to fire	52	0%
Material twisted/bent	52	0%
Difficult to insertthe device was hard to insert	42	0%
Insufficient device problem information	40	0%
Premature discharge of battery	38	0%
Computer software problema software problem	37	0%
No display/image	28	0%
Data problem	27	0%
Power problem	25	0%

Questions about sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated reports

What is product code PZE?

FDA's classification code for "Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

133,421 reports through August 2026, 19,450 of them in the latest 12 months.

Which brands appear most often?

Libre Sensor Freestyle (77,759), Freestyle Libre 14 Day (25,815), FreeStyle Libre Sensor 14 Day (13,292), FreeStyle LibreLink (8,108) and FreeStyle Libre (5,957). 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.