Devices › Device types
FDA product code PQF · class 3 · Unknown
Sensor, glucose, invasive, non-adjunctive: medical device reports filed with FDA
325,941 reports carry this product code, 2016–2026; 30 brands with a page.
- 325,941
- reports with this product code
- 1.3% of all MAUDE reports
- 31,055
- reports, 12 months to August 2026
- 33,000 in the 12 months before
- 99.3%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code PQF is FDA's classification for "Sensor, glucose, invasive, non-adjunctive" (unknown panel), a class 3 device. 325,941 medical device reports carry this product code, 1.3% of the MAUDE database, from March 2016 to August 2026.
31,055 reports arrived in the 12 months to August 2026, close to the 33,000 of 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 (99.3%) and injury (0.7%). 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 |
|---|---|---|
| Dexcom | 242,852 | 74.5% |
| Medtronic Minimed | 82,929 | 25.4% |
| Tandem Diabetes Care | 20 | 0% |
| Abbott Diabetes Care | 1 | 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 |
|---|---|---|
| Wireless communication problema wireless connection problem | 170,470 | 52.3% |
| Imprecision | 51,355 | 15.8% |
| Device displays incorrect message | 28,079 | 8.6% |
| No device output | 25,215 | 7.7% |
| Invalid sensing | 6,721 | 2.1% |
| Premature end-of-life indicator | 4,963 | 1.5% |
| Display or visual feedback problem | 4,349 | 1.3% |
| Communication or transmission problemthe device could not communicate or transmit | 4,125 | 1.3% |
| Unable to obtain readings | 4,083 | 1.3% |
| Defective alarm | 4,066 | 1.2% |
| Device inoperablethe device could not be used | 3,759 | 1.2% |
| Inappropriate or unexpected reset | 3,621 | 1.1% |
| Incorrect, inadequate or imprecise result or readings | 3,046 | 0.9% |
| Detachment of device or device componentpart of the device came off | 2,964 | 0.9% |
| Unexpected shutdown | 2,845 | 0.9% |
| Battery problema problem with the battery | 2,475 | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 2,209 | 0.7% |
| Calibration problem | 1,964 | 0.6% |
| Low battery | 1,878 | 0.6% |
| Connection problema connection problem | 1,593 | 0.5% |
Questions about sensor, glucose, invasive, non-adjunctive reports
What is product code PQF?
FDA's classification code for "Sensor, glucose, invasive, non-adjunctive", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
325,941 reports through August 2026, 31,055 of them in the latest 12 months.
Which brands appear most often?
Dexcom G5 Mobile Continuous Glucose Monitoring System (240,495), Transmitter Mmt-7841zn Gst5g Us (42,011), Transmitter Mmt-7841zw Gst5g Ous (29,824), Sensor Mmt-5120c Instinct 780 5pk Ous 1 (1,753) and Sensor Mmt-5120d1 Instinct 780 1pk Ous 1 (1,530). 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.