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FDA product code QBJ · class 2 · Clinical Chemistry
Integrated continuous glucose monitoring system, factory calibrated: medical device reports filed with FDA
2,268,325 reports carry this product code, 2007–2026; 30 brands with a page.
- 2,268,325
- reports with this product code
- 8.7% of all MAUDE reports
- 585,486
- reports, 12 months to August 2026
- 378,531 in the 12 months before
- 98.1%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code QBJ is FDA's classification for "Integrated continuous glucose monitoring system, factory calibrated" (clinical Chemistry panel), a class 2 device. 2,268,325 medical device reports carry this product code, 8.7% of the MAUDE database, from May 2007 to August 2026.
585,486 reports arrived in the 12 months to August 2026, up 55% from 378,531 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 (98.1%) and injury (1.9%). 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 | 2,007,288 | 88.5% |
| Abbott Diabetes Care | 260,623 | 11.5% |
| Tandem Diabetes Care | 75 | 0% |
| Abbott Laboratories | 26 | 0% |
| Senseonics | 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 | 809,254 | 35.7% |
| No device output | 298,849 | 13.2% |
| Incorrect, inadequate or imprecise result or readings | 235,775 | 10.4% |
| Low readingsreadings were too low | 160,293 | 7.1% |
| Detachment of device or device componentpart of the device came off | 131,657 | 5.8% |
| Imprecision | 110,410 | 4.9% |
| Premature end-of-life indicator | 107,518 | 4.7% |
| Unintended application program shut down | 71,127 | 3.1% |
| Protective measures problem | 58,880 | 2.6% |
| Communication or transmission problemthe device could not communicate or transmit | 30,913 | 1.4% |
| Breakthe device broke | 25,773 | 1.1% |
| Inappropriate or unexpected reset | 21,831 | 1% |
| Device displays incorrect message | 21,788 | 1% |
| Unexpected shutdown | 17,386 | 0.8% |
| High readingsreadings were too high | 16,965 | 0.7% |
| No audible alarm | 16,773 | 0.7% |
| Defective alarm | 15,944 | 0.7% |
| Unable to obtain readings | 13,996 | 0.6% |
| Display or visual feedback problem | 12,002 | 0.5% |
| Device alarm system | 10,400 | 0.5% |
Questions about integrated continuous glucose monitoring system, factory calibrated reports
What is product code QBJ?
FDA's classification code for "Integrated continuous glucose monitoring system, factory calibrated", 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?
2,268,325 reports through August 2026, 585,486 of them in the latest 12 months.
Which brands appear most often?
Dexcom G6 Continuous Glucose Monitoring System (1,338,454), Dexcom G7 Continuous Glucose Monitoring System (641,506), FreeStyle Libre 3 (108,895), FreeStyle Libre 3 Plus (91,086) and FreeStyle Libre 2 Plus (49,533). 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.