Devices › Pump, infusion, insulin
Device brand name · Insulin pump
Cozmo Insulin Pump: medical device reports filed with FDA
738 reports name it, 2003–2012. Product code LZG.
- 738
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.6%
- classified as malfunction
- 81.6% across the product code
- 1.5%
- classified as death, as reported
- 11 reports · not verified by FDA
FDA's MAUDE database holds 738 reports that name the brand "Cozmo Insulin Pump" (insulin pump), received between April 2003 and May 2012. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 injury (96.9%), malfunction (1.6%) and death (1.5%); 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 replace (4.3%), device alarm system (2.3%) and crack (1.6%). The patient problems coded most often are hospitalization required, hyperglycemia 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
No report naming Cozmo Insulin Pump was received in the five years to August 2026; the latest was received in May 2012.
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 |
|---|---|---|---|
| Replace | 32 | 4.3% | 0.6% |
| Device alarm system | 17 | 2.3% | 1.2% |
| Crackthe device cracked | 12 | 1.6% | 3.8% |
| Component(s), broken | 11 | 1.5% | 0% |
| Device damaged prior to usethe device was damaged before use | 10 | 1.4% | 0% |
| Device displays incorrect message | 10 | 1.4% | 6.8% |
| Alarm, audible | 9 | 1.2% | 0.4% |
| Failure to power up | 9 | 1.2% | 0.4% |
| Repair | 9 | 1.2% | 0.2% |
| Failure to deliverthe device did not deliver the dose or item | 8 | 1.1% | 0.5% |
| High test results | 7 | 0.9% | 0.4% |
| Disconnection | 6 | 0.8% | 0.1% |
| Overdelivery | 6 | 0.8% | 0% |
| Bent | 5 | 0.7% | 1.4% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 0.7% | 0.1% |
| Application program problem: dose calculation error | 4 | 0.5% | 0% |
| Battery failure | 4 | 0.5% | 0.1% |
| Excess flow or over-infusion | 4 | 0.5% | 0.3% |
| Kinkedthe tube or line kinked | 4 | 0.5% | 0.5% |
| No audible alarm | 4 | 0.5% | 0.2% |
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 |
|---|---|---|
| Hospitalization required | 632 | 85.6% |
| Hyperglycemiahigh blood sugar | 352 | 47.7% |
| Elevated ketones/ diabetic ketoacidosis | 222 | 30.1% |
| Blood glucose, high | 109 | 14.8% |
| Treatment with medication(s) | 107 | 14.5% |
| Hypoglycemialow blood sugar | 89 | 12.1% |
| Therapy/non-surgical treatment, additional | 63 | 8.5% |
| Vomitingbeing sick | 58 | 7.9% |
| Blood glucose, low | 24 | 3.3% |
| Loss of consciousnesspassing out | 19 | 2.6% |
| Other (for use when an appropriate patient code cannot be identified) | 13 | 1.8% |
| Overmedicated | 10 | 1.4% |
| Deaththe patient died; cause not stated by this term | 7 | 0.9% |
| Seizures | 7 | 0.9% |
| Overdosea dose above the recommended amount | 6 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cozmo Insulin Pump | Product code LZG | All MAUDE reports |
|---|---|---|---|
| Reports | 738 | 539,975 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 15 | 3 | 9 |
| Classified as injury | 96.9% | 17.8% | 36.2% |
| Classified as malfunction | 1.6% | 81.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 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% |
| Omnipod Insulin Management System | 37,582 | 218 | 0.1% |
| 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% |
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 Cozmo Insulin Pump reports
How many FDA reports name Cozmo Insulin Pump?
738 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (96.9%), malfunction (1.6%) and death (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (4.3%), device alarm system (2.3%), crack (1.6%), component(s), broken (1.5%) and device damaged prior to use (1.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cozmo Insulin Pump 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.