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FDA product code LFR · class 2 · Clinical Chemistry
Glucose dehydrogenase, glucose: medical device reports filed with FDA
74,282 reports carry this product code, 1998–2026; 30 brands with a page.
- 74,282
- reports with this product code
- 0.3% of all MAUDE reports
- 780
- reports, 12 months to August 2026
- 658 in the 12 months before
- 93%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code LFR is FDA's classification for "Glucose dehydrogenase, glucose" (clinical Chemistry panel), a class 2 device. 74,282 medical device reports carry this product code, 0.3% of the MAUDE database, from June 1998 to August 2026.
780 reports arrived in the 12 months to August 2026, up 19% from 658 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 (93%) and injury (6.9%). 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 |
|---|---|---|
| Roche Diagnostics | 39,628 | 53.3% |
| Abbott Diabetes Care USA | 21,654 | 29.2% |
| Roche Diabetes Care | 5,088 | 6.8% |
| Abbott Diabetes Care | 5,044 | 6.8% |
| Therasense | 1,094 | 1.5% |
| Nipro Diagnostics | 274 | 0.4% |
| Bayer Healthcare | 179 | 0.2% |
| Medisense | 103 | 0.1% |
| Lifescan | 48 | 0.1% |
| Abbott Diabetes Care UK | 32 | 0% |
| Insulet | 27 | 0% |
| Abbott | 18 | 0% |
| Trividia Health | 8 | 0% |
| Lifescan Europe | 7 | 0% |
| Ascensia Diabetes Care US | 5 | 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 |
|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 24,874 | 33.5% |
| Incorrect or inadequate test results | 19,163 | 25.8% |
| Use of incorrect control/treatment settings | 13,074 | 17.6% |
| Loss of data | 4,882 | 6.6% |
| Replace | 4,422 | 6% |
| High test results | 2,977 | 4% |
| Device displays incorrect message | 2,824 | 3.8% |
| Computer operating system problem | 2,532 | 3.4% |
| Battery problema problem with the battery | 2,237 | 3% |
| Reset problem | 2,232 | 3% |
| Device issuea problem with the device | 1,607 | 2.2% |
| Malfunction | 1,211 | 1.6% |
| Low test results | 1,205 | 1.6% |
| Improper device output | 1,149 | 1.5% |
| Imprecise or erratic results | 754 | 1% |
| Computer software problema software problem | 691 | 0.9% |
| Computer hardware error | 671 | 0.9% |
| No display/image | 616 | 0.8% |
| Device expiration issue | 495 | 0.7% |
| Self-activation or keying | 465 | 0.6% |
Questions about glucose dehydrogenase, glucose reports
What is product code LFR?
FDA's classification code for "Glucose dehydrogenase, glucose", 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?
74,282 reports through August 2026, 780 of them in the latest 12 months.
Which brands appear most often?
Freestyle Flash (18,976), Accu-Chek Comfort Curve Test Strips (11,710), Accu-Chek Aviva Test Strips (9,599), Accu-Chek Compact Test Drum (6,860) and Freestyle (6,765). 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.