Devices › Alternate controller enabled insulin infusion pump
Device brand name · Alternate controller enabled insulin infusion pump
iLet Bionic Pancreas: medical device reports filed with FDA
62,887 reports name it, 2023–2026. Manufacturer given most often on reports: Beta Bionics. Product code QFG.
- 62,887
- device reports naming the brand
- 0.2% of all MAUDE reports · about 21,588 a year
- 60,771
- reports, 12 months to August 2026
- 1,719 in the 12 months before
- 76.4%
- classified as malfunction
- 88.9% across the product code
- 0.1%
- classified as death, as reported
- 42 reports · not verified by FDA
62,887 medical device reports received by FDA name the brand "iLet Bionic Pancreas" (alternate controller enabled insulin infusion pump); the manufacturer given most often on reports is Beta Bionics; received from August 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
60,771 reports arrived in the 12 months to August 2026, up 3435% from 1,719 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 (76.4%), injury (23.5%) and death (0.1%); across all alternate controller enabled insulin infusion pump reports (product code QFG) death is recorded in 0% and malfunction in 88.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (31.5%), improper or incorrect procedure or method (20%) and intermittent communication failure (10.3%). The patient problems coded most often are hyperglycemia, hypoglycemia and shaking/tremors. 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 1,297,995 reports carrying product code QFG. 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 |
|---|---|---|---|
| Insufficient device problem information | 19,832 | 31.5% | 3.2% |
| Improper or incorrect procedure or method | 12,553 | 20% | 1% |
| Intermittent communication failure | 6,468 | 10.3% | 0.5% |
| Fracturea broken bone | 3,982 | 6.3% | 0.6% |
| Key or button unresponsive/not working | 2,560 | 4.1% | 1.4% |
| Failure to infuse | 1,980 | 3.1% | 0.2% |
| Obstruction of flow | 1,901 | 3% | 6.4% |
| Charging problem | 1,459 | 2.3% | 7.4% |
| Leak/splashthe device leaked | 1,288 | 2% | 0.7% |
| Fitting problem | 892 | 1.4% | 0.5% |
| Premature discharge of battery | 796 | 1.3% | 0.8% |
| Mechanical jam | 772 | 1.2% | 0.1% |
| Loss of or failure to bond | 675 | 1.1% | 6.1% |
| Complete blockage | 655 | 1% | 0.1% |
| Patient device interaction problem | 468 | 0.7% | 0% |
| Fluid/blood leak | 388 | 0.6% | 1.6% |
| Display difficult to read | 361 | 0.6% | 0% |
| Failure to disconnect | 359 | 0.6% | 0% |
| Breakthe device broke | 196 | 0.3% | 1.1% |
| Failure to read input signal | 195 | 0.3% | 0% |
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 | 26,098 | 41.5% |
| Hypoglycemialow blood sugar | 14,340 | 22.8% |
| Shaking/tremors | 1,588 | 2.5% |
| Dizzinesslight-headedness or unsteadiness | 1,435 | 2.3% |
| Confusion/ disorientation | 1,238 | 2% |
| Nauseafeeling sick | 1,200 | 1.9% |
| Headachehead pain | 1,101 | 1.8% |
| Polydipsia | 1,044 | 1.7% |
| Elevated ketones/ diabetic ketoacidosis | 960 | 1.5% |
| Diaphoresis | 873 | 1.4% |
| Fatiguetiredness | 840 | 1.3% |
| Loss of consciousnesspassing out | 766 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 689 | 1.1% |
| Vomitingbeing sick | 684 | 1.1% |
| Dry mouthdry mouth | 642 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | iLet Bionic Pancreas | Product code QFG | All MAUDE reports |
|---|---|---|---|
| Reports | 62,887 | 1,297,995 | 26,136,888 |
| Share of that pool | — | 4.8% | 0.2% |
| Classified as death, per 1,000 reports | 1 | 0 | 9 |
| Classified as injury | 23.5% | 11.1% | 36.2% |
| Classified as malfunction | 76.4% | 88.9% | 62.3% |
| Filed by the manufacturer | 100% | 99.9% | 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 QFG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| t:slim X2 Insulin Pump with Control-IQ Technology | 584,236 | 129,119 | 0% |
| t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | 267,716 | 11,502 | 0% |
| Omnipod 5 Pod | 72,516 | 13,913 | 0.1% |
| t:slim X2 Insulin Pump with Control-IQ+ Technology | 65,298 | 57,936 | 0% |
| Omnipod 5 Pods | 53,253 | 34,593 | 0% |
| Omnipod 5 Automated Insulin Delivery System | 50,523 | 32,478 | 0% |
| t:slim X2 Insulin Pump with Interoperable Technology | 37,136 | 865 | 0% |
| Tandem Mobi Insulin Pump with Control-IQ+ Technology | 36,506 | 31,674 | 0% |
| Tandem Mobi Insulin Pump with Interoperable Technology | 27,952 | 1,595 | 0% |
| Tandem Mobi Insulin Pump with Control-IQ Technology | 15,154 | 9,553 | 0% |
| MiniMed 780G US System BLE Connect 3.0 mg/dL | 112,817 | 57,140 | 0.1% |
| t:slim X2 Insulin Pump with Basal-IQ Technology | 142,641 | 1,916 | 0% |
| Omnipod 5 Controller | 2,618 | 926 | 0.8% |
| T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile A | 2,555 | 0 | 0% |
| PUMP MMT-1884L MM780G BLE 3.0 mg/ml | 34,846 | 9,703 | 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 iLet Bionic Pancreas reports
How many FDA reports name iLet Bionic Pancreas?
62,887 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 60,771 in the latest 12 months.
What kinds of events are reported?
malfunction (76.4%), injury (23.5%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (31.5%), improper or incorrect procedure or method (20%), intermittent communication failure (10.3%), fracture (6.3%) and key or button unresponsive/not working (4.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that iLet Bionic Pancreas 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.