Devices › Automated insulin dosing , threshold suspend
Device brand name · Artificial pancreas device system threshold suspend
630G Insulin PUMP MMT-1715KL 630G: medical device reports filed with FDA
35,095 reports name it, 2018–2026. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code OZO.
- 35,095
- device reports naming the brand
- 0.1% of all MAUDE reports · about 4,212 a year
- 945
- reports, 12 months to August 2026
- 2,112 in the 12 months before
- 79.9%
- classified as malfunction
- 79% across the product code
- 0.5%
- classified as death, as reported
- 183 reports · not verified by FDA
FDA's MAUDE database holds 35,095 reports that name the brand "630G Insulin PUMP MMT-1715KL 630G" (artificial pancreas device system threshold suspend), received between March 2018 and August 2026; the manufacturer given most often on reports is Medtronic Puerto Rico Operations. Spellings of one product vary from report to report.
945 reports arrived in the 12 months to August 2026, down 55% from 2,112 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 (79.9%), injury (19.6%) and death (0.5%); across all automated insulin dosing , threshold suspend reports (product code OZO) death is recorded in 0.3% and malfunction in 79%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (22.5%), power problem (22.4%) and obstruction of flow (15%). The patient problems coded most often are hyperglycemia, hypoglycemia 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 439,495 reports carrying product code OZO. 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 |
|---|---|---|---|
| Breakthe device broke | 7,895 | 22.5% | 9.5% |
| Power problem | 7,848 | 22.4% | 5.9% |
| Obstruction of flow | 5,277 | 15% | 7.1% |
| No display/image | 4,393 | 12.5% | 6.2% |
| Mechanical problema mechanical problem | 2,332 | 6.6% | 4.1% |
| Material integrity problema problem with the device material | 2,325 | 6.6% | 3.8% |
| Battery problema problem with the battery | 2,148 | 6.1% | 4.1% |
| Device difficult to program or calibrate | 2,103 | 6% | 3.4% |
| Patient device interaction problem | 2,098 | 6% | 7.6% |
| Moisture or humidity problem | 1,020 | 2.9% | 1.3% |
| Insufficient flow or under infusion | 1,013 | 2.9% | 1% |
| Connection problema connection problem | 873 | 2.5% | 2.1% |
| Display or visual feedback problem | 801 | 2.3% | 1.2% |
| Key or button unresponsive/not working | 725 | 2.1% | 0.3% |
| Device alarm system | 581 | 1.7% | 1.6% |
| Priming problem | 448 | 1.3% | 0.8% |
| Excess flow or over-infusion | 435 | 1.2% | 0.5% |
| Insufficient device problem information | 347 | 1% | 1.8% |
| Circuit failure | 312 | 0.9% | 0.5% |
| Electrical /electronic property probleman electrical or electronic problem | 249 | 0.7% | 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 |
|---|---|---|
| Hyperglycemiahigh blood sugar | 6,241 | 17.8% |
| Hypoglycemialow blood sugar | 1,882 | 5.4% |
| Elevated ketones/ diabetic ketoacidosis | 575 | 1.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 259 | 0.7% |
| Nauseafeeling sick | 206 | 0.6% |
| Vomitingbeing sick | 180 | 0.5% |
| Loss of consciousnesspassing out | 119 | 0.3% |
| Fatiguetiredness | 109 | 0.3% |
| Confusion/ disorientation | 99 | 0.3% |
| Headachehead pain | 83 | 0.2% |
| Malaisegeneral feeling of being unwell | 73 | 0.2% |
| Polydipsia | 70 | 0.2% |
| Dyspneashortness of breath | 61 | 0.2% |
| Abdominal painstomach or belly pain | 56 | 0.2% |
| Dizzinesslight-headedness or unsteadiness | 41 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 630G Insulin PUMP MMT-1715KL 630G | Product code OZO | All MAUDE reports |
|---|---|---|---|
| Reports | 35,095 | 439,495 | 26,136,888 |
| Share of that pool | — | 8% | 0.1% |
| Classified as death, per 1,000 reports | 5 | 3 | 9 |
| Classified as injury | 19.6% | 20.6% | 36.2% |
| Classified as malfunction | 79.9% | 79% | 62.3% |
| Filed by the manufacturer | 100% | 100% | 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 OZO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| t:slim X2 Insulin Pump with Basal-IQ Technology | 142,641 | 1,916 | 0% |
| 630G Insulin PUMP MMT-1715K 630G BLACK MG | 86,016 | 583 | 0.4% |
| 530g Insulin Pump | 59,083 | 0 | 0.8% |
| Sensor Enlite | 17,978 | 0 | 0% |
| Pump Mmt-1715km 630g 3ml Black Medi | 16,204 | 18 | 0.8% |
| Pump Mmt-1714k 630g Black Mmol Canada | 12,875 | 73 | 0.2% |
| 530g Insulin Pump Mmt-751nas | 12,062 | 32 | 0.6% |
| Sensor Enlite Mmt-7008a | 10,133 | 13 | 0.3% |
| 530G Insulin Pump MMT-751LNAS | 9,062 | 31 | 0.3% |
| 630G Insulin PUMP MMT-1715KR 630G | 5,126 | 161 | 0.8% |
| 530g Insulin Pump Mmt-751nal | 4,753 | 1 | 0.4% |
| 530G Insulin Pump MMT-551NAS | 4,322 | 8 | 0.3% |
| 530g Insulin Pump Mmt-751nab | 3,866 | 6 | 0.4% |
| 530g Insulin Pump Mmt-751nap | 3,596 | 3 | 0.4% |
| T Slim X2 Basal-Iq Mmol/L | 3,121 | 0 | 0% |
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 630G Insulin PUMP MMT-1715KL 630G reports
How many FDA reports name 630G Insulin PUMP MMT-1715KL 630G?
35,095 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 945 in the latest 12 months.
What kinds of events are reported?
malfunction (79.9%), injury (19.6%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (22.5%), power problem (22.4%), obstruction of flow (15%), no display/image (12.5%) and mechanical problem (6.6%). 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 630G Insulin PUMP MMT-1715KL 630G 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.