Devices › Pump, infusion, insulin
Device brand name · Pump infusion insulin
Omnipod Insulin Management System: medical device reports filed with FDA
37,582 reports name it, 2011–2026. Manufacturer given most often on reports: Insulet. Product code LZG.
- 37,582
- device reports naming the brand
- 0.1% of all MAUDE reports · about 2,439 a year
- 218
- reports, 12 months to August 2026
- 551 in the 12 months before
- 91.8%
- classified as malfunction
- 81.6% across the product code
- 0.1%
- classified as death, as reported
- 20 reports · not verified by FDA
37,582 medical device reports received by FDA name the brand "Omnipod Insulin Management System" (pump infusion insulin); the manufacturer given most often on reports is Insulet; received from February 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
218 reports arrived in the 12 months to August 2026, down 60% from 551 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 (91.8%), injury (8.1%) and death (0.1%); across all pump, infusion, insulin reports (product code LZG) death is recorded in 0.3% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material twisted/bent (31.3%), unintended movement (20.8%) and loss of or failure to bond (12.8%). The patient problems coded most often are hyperglycemia, pain and elevated ketones/ diabetic ketoacidosis. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 539,975 reports carrying product code LZG. 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 |
|---|---|---|---|
| Material twisted/bent | 11,763 | 31.3% | 6.5% |
| Unintended movement | 7,827 | 20.8% | 7.6% |
| Loss of or failure to bond | 4,818 | 12.8% | 4.6% |
| Insufficient device problem information | 4,314 | 11.5% | 5% |
| Activation, positioning or separation problem | 3,307 | 8.8% | 2% |
| Failure to fire | 3,027 | 8.1% | 2.2% |
| Difficult to insertthe device was hard to insert | 2,441 | 6.5% | 1.7% |
| Fluid/blood leak | 2,325 | 6.2% | 2.2% |
| Positioning failure | 2,166 | 5.8% | 1% |
| Premature activation | 2,126 | 5.7% | 1.2% |
| Retraction problem | 1,986 | 5.3% | 0.8% |
| Difficult or delayed activation | 234 | 0.6% | 2.2% |
| Material split, cut or torn | 122 | 0.3% | 0.1% |
| Failure to reset | 32 | 0.1% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 27 | 0.1% | 0.1% |
| Failure to power up | 27 | 0.1% | 0.4% |
| Leak/splashthe device leaked | 27 | 0.1% | 0.7% |
| Excess flow or over-infusion | 19 | 0.1% | 0.3% |
| Device alarm system | 12 | 0% | 1.2% |
| Reset problem | 12 | 0% | 0.1% |
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.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperglycemiahigh blood sugar | 26,337 | 70.1% |
| Painpain, site not specified | 819 | 2.2% |
| Elevated ketones/ diabetic ketoacidosis | 674 | 1.8% |
| Skin inflammation/ irritation | 501 | 1.3% |
| Vomitingbeing sick | 491 | 1.3% |
| Hypoglycemialow blood sugar | 374 | 1% |
| Irritationirritation | 340 | 0.9% |
| Nauseafeeling sick | 294 | 0.8% |
| Purulent discharge | 254 | 0.7% |
| Skin infection | 244 | 0.6% |
| Skin irritationirritated skin | 241 | 0.6% |
| Itching sensation | 177 | 0.5% |
| Bruise/contusion | 164 | 0.4% |
| Loss of consciousnesspassing out | 132 | 0.4% |
| Dehydrationdehydration | 109 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Omnipod Insulin Management System | Product code LZG | All MAUDE reports |
|---|---|---|---|
| Reports | 37,582 | 539,975 | 26,136,888 |
| Share of that pool | — | 7% | 0.1% |
| Classified as death, per 1,000 reports | 1 | 3 | 9 |
| Classified as injury | 8.1% | 17.8% | 36.2% |
| Classified as malfunction | 91.8% | 81.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.8% | 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 LZG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Onetouchping Glucosemgmtsystem | 98,945 | 0 | 0.1% |
| Omnipod DASH Insulin Management System | 62,646 | 5,563 | 0.1% |
| Tandem T Slim Insulin Delivery System | 55,207 | 0 | 0.1% |
| OmniPod Insulin Pump | 45,272 | 145 | 0.3% |
| Animas Vibe | 88,703 | 0 | 0% |
| Animas Insulin Infusion Pump | 26,293 | 0 | 0.3% |
| MMT-712 PARADIGM Insulin Pump | 25,781 | 4,138 | 0% |
| Accu-Chek Spirit Combo | 21,252 | 0 | 0.1% |
| t:slim Insulin Delivery System | 19,277 | 30 | 0.1% |
| t:slim X2 Insulin Pump | 31,159 | 86 | 0% |
| Animas Insulin Cartridge | 12,105 | 0 | 0% |
| T Flex Insulin Delivery System | 11,359 | 0 | 0.1% |
| Paradigm Insulin Infusion Pump | 16,324 | 0 | 0.4% |
| Accu-Chek Spirit | 8,826 | 0 | 0.3% |
| MMT-715 PARADIGM Insulin Pump | 5,498 | 136 | 0.1% |
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 Omnipod Insulin Management System reports
How many FDA reports name Omnipod Insulin Management System?
37,582 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 218 in the latest 12 months.
What kinds of events are reported?
malfunction (91.8%), injury (8.1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material twisted/bent (31.3%), unintended movement (20.8%), loss of or failure to bond (12.8%), insufficient device problem information (11.5%) and activation, positioning or separation problem (8.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Omnipod Insulin Management System 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.