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FDA product code QFG · class 2 · Clinical Chemistry
Alternate controller enabled insulin infusion pump: medical device reports filed with FDA
1,297,995 reports carry this product code, 2020–2026; 30 brands with a page.
- 1,297,995
- reports with this product code
- 5% of all MAUDE reports
- 400,824
- reports, 12 months to August 2026
- 295,187 in the 12 months before
- 88.9%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code QFG is FDA's classification for "Alternate controller enabled insulin infusion pump" (clinical Chemistry panel), a class 2 device. 1,297,995 medical device reports carry this product code, 5% of the MAUDE database, from January 2020 to August 2026.
400,824 reports arrived in the 12 months to August 2026, up 36% from 295,187 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 (88.9%) and injury (11.1%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Tandem Diabetes Care | 1,042,455 | 80.3% |
| Insulet | 179,538 | 13.8% |
| Beta Bionics | 62,321 | 4.8% |
| Medtronic Puerto Rico Operations | 12,398 | 1% |
| Medtronic Minimed | 151 | 0% |
| Dexcom | 18 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Pumping stopped | 351,869 | 27.1% |
| Charging problem | 95,979 | 7.4% |
| Incorrect measurementthe device measured wrongly | 87,904 | 6.8% |
| Unintended movement | 85,989 | 6.6% |
| Obstruction of flow | 82,815 | 6.4% |
| Loss of or failure to bond | 78,769 | 6.1% |
| Battery problema problem with the battery | 68,262 | 5.3% |
| Communication or transmission problemthe device could not communicate or transmit | 60,678 | 4.7% |
| Failure to sense | 42,257 | 3.3% |
| Insufficient device problem information | 41,982 | 3.2% |
| Mechanical problema mechanical problem | 36,170 | 2.8% |
| Material twisted/bent | 35,341 | 2.7% |
| Filling problem | 31,776 | 2.4% |
| False alarm | 30,787 | 2.4% |
| Crackthe device cracked | 25,430 | 2% |
| Failure to charge | 24,943 | 1.9% |
| Fluid/blood leak | 20,655 | 1.6% |
| Device sensing problem | 20,644 | 1.6% |
| Poor quality image | 20,026 | 1.5% |
| Key or button unresponsive/not working | 18,155 | 1.4% |
Questions about alternate controller enabled insulin infusion pump reports
What is product code QFG?
FDA's classification code for "Alternate controller enabled insulin infusion pump", class 2, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.
How many reports carry this code?
1,297,995 reports through August 2026, 400,824 of them in the latest 12 months.
Which brands appear most often?
t:slim X2 Insulin Pump with Control-IQ Technology (584,157), t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (267,584), Omnipod 5 Pod (72,514), t:slim X2 Insulin Pump with Control-IQ+ Technology (65,298) and iLet Bionic Pancreas (62,863). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.