Devices › Pump, infusion, insulin, to be used with invasive glucose sensor
Device brand name · Pump infusion insulin to be used with invasive glucose sensor
Unknown PARADIGM: medical device reports filed with FDA
435 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic Minimed. Product code OYC.
- 435
- device reports naming the brand
- 0% of all MAUDE reports · about 119 a year
- 162
- reports, 12 months to August 2026
- 124 in the 12 months before
- 91.5%
- classified as malfunction
- 85.5% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 435 reports that name the brand "Unknown PARADIGM" (pump infusion insulin to be used with invasive glucose sensor), received between November 2022 and August 2026; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.
162 reports arrived in the 12 months to August 2026, up 31% from 124 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 (91.5%), injury (8.3%) and death (0.2%); across all pump, infusion, insulin, to be used with invasive glucose sensor reports (product code OYC) death is recorded in 0.3% and malfunction in 85.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are obstruction of flow (54.5%), mechanical problem (10.1%) and break (5.7%). The patient problems coded most often are hyperglycemia, hypoglycemia and appropriate clinical signs, symptoms and conditions term/code not available. 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 891,173 reports carrying product code OYC. 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 |
|---|---|---|---|
| Obstruction of flow | 237 | 54.5% | 3% |
| Mechanical problema mechanical problem | 44 | 10.1% | 3.7% |
| Breakthe device broke | 25 | 5.7% | 10.1% |
| No display/image | 21 | 4.8% | 5% |
| Failure to cycle | 15 | 3.4% | 0.7% |
| Power problem | 12 | 2.8% | 4.9% |
| Battery problema problem with the battery | 11 | 2.5% | 3.1% |
| Device difficult to program or calibrate | 10 | 2.3% | 2.8% |
| Key or button unresponsive/not working | 10 | 2.3% | 0.3% |
| Detachment of device or device componentpart of the device came off | 9 | 2.1% | 0.6% |
| Material integrity problema problem with the device material | 9 | 2.1% | 2.7% |
| Insufficient flow or under infusion | 7 | 1.6% | 0.7% |
| Premature discharge of battery | 7 | 1.6% | 0.8% |
| Insufficient device problem information | 5 | 1.1% | 2.1% |
| Priming problem | 4 | 0.9% | 0.4% |
| Failure of device to self-test | 3 | 0.7% | 0.3% |
| Visual prompts will not clear | 3 | 0.7% | 0.7% |
| Wireless communication problema wireless connection problem | 3 | 0.7% | 1.3% |
| Fracturea broken bone | 2 | 0.5% | 0.2% |
| Loss of data | 2 | 0.5% | 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 |
|---|---|---|
| Hyperglycemiahigh blood sugar | 37 | 8.5% |
| Hypoglycemialow blood sugar | 8 | 1.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.9% |
| Elevated ketones/ diabetic ketoacidosis | 3 | 0.7% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
| Confusion/ disorientation | 1 | 0.2% |
| Discomfortdiscomfort | 1 | 0.2% |
| Itching sensation | 1 | 0.2% |
| Loss of consciousnesspassing out | 1 | 0.2% |
| Malaisegeneral feeling of being unwell | 1 | 0.2% |
| Renal failurekidney failure | 1 | 0.2% |
| Viral infectiona viral infection | 1 | 0.2% |
| Vomitingbeing sick | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown PARADIGM | Product code OYC | All MAUDE reports |
|---|---|---|---|
| Reports | 435 | 891,173 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 2 | 3 | 9 |
| Classified as injury | 8.3% | 14.2% | 36.2% |
| Classified as malfunction | 91.5% | 85.5% | 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 OYC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Paradigm Real-Time Revel Insulin Infusion Pump | 178,691 | 0 | 0.6% |
| Paradigm Real-Time Insulin Infusion Pump | 126,282 | 0 | 0.3% |
| 640G Insulin Pump MMT-1712K | 119,547 | 1,598 | 0.1% |
| 640G Insulin Pump MMT-1711K | 76,609 | 151 | 0.1% |
| Animas Vibe | 88,703 | 0 | 0% |
| T Slim G5 System | 49,783 | 0 | 0% |
| t:slim G4 system | 39,215 | 20 | 0% |
| Pump Mmt-1712kl 640g V4 10 Bk Sf Mg | 21,531 | 952 | 0% |
| 640g Insulin Pump | 16,911 | 0 | 0% |
| Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNAS | 12,936 | 41 | 0.8% |
| t:slim X2 Insulin Pump | 31,159 | 86 | 0% |
| Pump Mmt-1711kl 640g V4 10 Bk Sf Mm | 11,157 | 168 | 0% |
| Paradigm REAL-Time Insulin Infusion Pump MMT-754WWS | 10,465 | 661 | 0% |
| Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723nas | 8,540 | 49 | 0.8% |
| 640g Insulin Pump Mmt-1712b | 5,629 | 1 | 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 Unknown PARADIGM reports
How many FDA reports name Unknown PARADIGM?
435 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 162 in the latest 12 months.
What kinds of events are reported?
malfunction (91.5%), injury (8.3%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
obstruction of flow (54.5%), mechanical problem (10.1%), break (5.7%), no display/image (4.8%) and failure to cycle (3.4%). 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 Unknown PARADIGM 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.