Devices › Pump, infusion, insulin
Device brand name · Infusion pump
Pump Mmt-515nas Prdgm Ins V2 1 Sk En: medical device reports filed with FDA
154 reports name it, 2007–2010. Manufacturer given most often on reports: Medtronic Puerto Rico Operations Med-Rel. Product code LZG.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 24.7%
- classified as malfunction
- 81.6% across the product code
- 5.2%
- classified as death, as reported
- 8 reports · not verified by FDA
154 medical device reports received by FDA name the brand "Pump Mmt-515nas Prdgm Ins V2 1 Sk En" (infusion pump); the manufacturer given most often on reports is Medtronic Puerto Rico Operations Med-Rel; received from March 2007 to December 2010. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (70.1%), malfunction (24.7%) and death (5.2%); 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 device displays incorrect message (15.6%), alarm, audible (14.9%) and insufficient device problem information (10.4%). The patient problems coded most often are hospitalization required, blood glucose, high and hyperglycemia. 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 Pump Mmt-515nas Prdgm Ins V2 1 Sk En was received in the five years to August 2026; the latest was received in December 2010.
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 |
|---|---|---|---|
| Device displays incorrect message | 24 | 15.6% | 6.8% |
| Alarm, audible | 23 | 14.9% | 0.4% |
| Insufficient device problem information | 16 | 10.4% | 5% |
| Device operates differently than expectedthe device behaved unexpectedly | 12 | 7.8% | 4.7% |
| No display/image | 8 | 5.2% | 3.1% |
| Failure to deliverthe device did not deliver the dose or item | 6 | 3.9% | 0.5% |
| Moisture damage | 6 | 3.9% | 1.2% |
| Replace | 6 | 3.9% | 0.6% |
| Device issuea problem with the device | 5 | 3.2% | 0.3% |
| Excess flow or over-infusion | 5 | 3.2% | 0.3% |
| Improper or incorrect procedure or method | 5 | 3.2% | 1.1% |
| Device alarm system | 3 | 1.9% | 1.2% |
| Device inoperablethe device could not be used | 3 | 1.9% | 2.6% |
| Failure to prime | 3 | 1.9% | 2.7% |
| Magnetic interference | 3 | 1.9% | 0% |
| Motor failure | 3 | 1.9% | 0% |
| Normal | 3 | 1.9% | 0% |
| Suspect emi | 3 | 1.9% | 0% |
| Electromagnetic interference | 2 | 1.3% | 0% |
| Scratched material | 2 | 1.3% | 0.3% |
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 | 61 | 39.6% |
| Blood glucose, high | 36 | 23.4% |
| Hyperglycemiahigh blood sugar | 30 | 19.5% |
| Elevated ketones/ diabetic ketoacidosis | 28 | 18.2% |
| Hypoglycemialow blood sugar | 25 | 16.2% |
| Blood glucose, low | 24 | 15.6% |
| Therapy/non-surgical treatment, additional | 10 | 6.5% |
| Treatment with medication(s) | 9 | 5.8% |
| Deaththe patient died; cause not stated by this term | 8 | 5.2% |
| Vomitingbeing sick | 8 | 5.2% |
| Overdosea dose above the recommended amount | 6 | 3.9% |
| Loss of consciousnesspassing out | 5 | 3.2% |
| Breathing difficulties | 2 | 1.3% |
| Chest painchest pain | 2 | 1.3% |
| Malaisegeneral feeling of being unwell | 2 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pump Mmt-515nas Prdgm Ins V2 1 Sk En | Product code LZG | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 539,975 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 52 | 3 | 9 |
| Classified as injury | 70.1% | 17.8% | 36.2% |
| Classified as malfunction | 24.7% | 81.6% | 62.3% |
| Filed by the manufacturer | 100% | 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 Pump Mmt-515nas Prdgm Ins V2 1 Sk En reports
How many FDA reports name Pump Mmt-515nas Prdgm Ins V2 1 Sk En?
154 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 (70.1%), malfunction (24.7%) and death (5.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (15.6%), alarm, audible (14.9%), insufficient device problem information (10.4%), device operates differently than expected (7.8%) and no display/image (5.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pump Mmt-515nas Prdgm Ins V2 1 Sk En 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.