Pump, infusion, insulin: medical device reports filed with FDA

539,975 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.

539,975
reports with this product code: 2.1% of all MAUDE reports; 11,317
reports, 12 months to August 2026: 13,483 in the 12 months before; 81.6%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code LZG is FDA's classification for "Pump, infusion, insulin" (general Hospital panel), a class 2 device. 539,975 medical device reports carry this product code, 2.1% of the MAUDE database, from July 1992 to August 2026.

11,317 reports arrived in the 12 months to August 2026, down 16% from 13,483 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 (81.6%), injury (17.8%) and death (0.3%). 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
Onetouchping Glucosemgmtsystem	98,806	0	0.1%	89.7%
Omnipod DASH Insulin Management System	62,636	5,563	0.1%	90.9%
Tandem T Slim Insulin Delivery System	55,201	0	0.1%	65.2%
OmniPod Insulin Pump	45,254	145	0.3%	75.5%
Omnipod Insulin Management System	37,580	218	0.1%	91.8%
Animas Vibe	29,287	0	0%	98%
Animas Insulin Infusion Pump	25,900	0	0.3%	88.1%
MMT-712 PARADIGM Insulin Pump	25,780	4,138	0%	97.5%
Accu-Chek Spirit Combo	21,231	0	0.1%	89.6%
t:slim Insulin Delivery System	19,275	30	0.1%	80.2%
t:slim X2 Insulin Pump	18,681	86	0%	81.9%
Animas Insulin Cartridge	12,014	0	0%	88%
T Flex Insulin Delivery System	11,356	0	0.1%	79.3%
Paradigm Insulin Infusion Pump	11,102	0	0.4%	89.4%
Accu-Chek Spirit	8,785	0	0.3%	67.4%
MMT-715 PARADIGM Insulin Pump	5,498	136	0.1%	92.1%
Omnipod DASH, PODS 10-PACK	4,941	1,022	0%	92.7%
Minimed Infusion Pump	3,679	0	2%	53.3%
One Touch Ping Glucose Management System	2,480	0	0.7%	72.2%
V-Go Disposable Insulin Delivery Device	2,091	14	1%	75.5%
Accu-Chek Insight Pump	1,824	0	0.1%	92.2%
H-Tronplus	1,499	0	0.9%	42.9%
Accu-Chek 3 15 Ml Insulin Cartridge	1,473	0	0%	94%
Pump Mmt-722nas Prdgm Ins V2 2 Sk En	1,355	0	2.6%	26.1%
D-Tronplus	998	0	0.1%	70.8%
Accu-Chek Spirit Cartridge	853	0	0%	61%
Cozmo Insulin Pump	738	0	1.5%	1.6%
Pump Mmt-522nas Prdgm Ins V2 2 Sk En	660	0	3.5%	31.5%
Pump Mmt-722nab Prdgm Ins V2 2 Bl En	606	0	2.1%	22.9%
Pump Mmt-722nal Prdgm Ins V2 2 Cl En Pr	577	0	2%	24.5%

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
Animas	169,184	31.3%
Insulet	150,933	28%
Tandem Diabetes Care	103,231	19.1%
Medtronic Puerto Rico Operations	37,020	6.9%
Medtronic Minimed	21,512	4%
Roche Diabetes Care	20,928	3.9%
Disetronic Medical Systems	9,125	1.7%
Medtronic Puerto Rico Operations Med-Rel	6,010	1.1%
Roche Insulin Delivery Systems	5,533	1%
Minimed	3,802	0.7%
Roche Diagnostics	3,045	0.6%
Roche Health Solutions	1,289	0.2%
Tandem Diabetes	1,117	0.2%
Valeritas	1,003	0.2%
Medtronic Puerto Rico Operations Juncos	75	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

Death0.3%1,411

Injury17.8%96,111

Malfunction81.6%440,655

Other0.1%730

Not given0.2%1,068

Who filed

Manufacturer report99.8%538,800

Voluntary report0.2%1,101

User facility report0%0

Distributor report0%38

Not given0%36

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

Device problems coded

Device problem (FDA code)	Reports	Share
Unintended movement	40,797	7.6%
Device displays incorrect message	36,683	6.8%
Material twisted/bent	34,839	6.5%
Insufficient device problem information	26,731	5%
Device operates differently than expectedthe device behaved unexpectedly	25,564	4.7%
Loss of or failure to bond	24,865	4.6%
Pumping stopped	20,974	3.9%
Crackthe device cracked	20,308	3.8%
Poor quality image	20,003	3.7%
Mechanical problema mechanical problem	19,141	3.5%
No display/image	16,756	3.1%
Breakthe device broke	15,488	2.9%
Failure to prime	14,356	2.7%
Device inoperablethe device could not be used	14,248	2.6%
Battery problema problem with the battery	12,554	2.3%
Fluid/blood leak	11,831	2.2%
Difficult or delayed activation	11,798	2.2%
Incorrect measurementthe device measured wrongly	11,715	2.2%
Failure to fire	11,673	2.2%
Activation, positioning or separation problem	10,584	2%

Questions about pump, infusion, insulin reports

What is product code LZG?

FDA's classification code for "Pump, infusion, insulin", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

539,975 reports through August 2026, 11,317 of them in the latest 12 months.

Which brands appear most often?

Onetouchping Glucosemgmtsystem (98,806), Omnipod DASH Insulin Management System (62,636), Tandem T Slim Insulin Delivery System (55,201), OmniPod Insulin Pump (45,254) and Omnipod Insulin Management System (37,580). 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.