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FDA product code CGA · class 2 · Clinical Chemistry
Glucose oxidase, glucose: medical device reports filed with FDA
7,612 reports carry this product code, 1997–2026; 30 brands with a page.
- 7,612
- reports with this product code
- 0% of all MAUDE reports
- 55
- reports, 12 months to August 2026
- 116 in the 12 months before
- 91%
- classified as malfunction
- 62.3% across all reports
- 0.2%
- classified as death, as reported
- 0.9% across all reports
Product code CGA is FDA's classification for "Glucose oxidase, glucose" (clinical Chemistry panel), a class 2 device. 7,612 medical device reports carry this product code, 0% of the MAUDE database, from May 1997 to August 2026.
55 reports arrived in the 12 months to August 2026, down 53% from 116 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 (91%), injury (7.8%) and other (0.6%). 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 |
|---|---|---|
| Lifescan | 2,883 | 37.9% |
| Medtronic Minimed | 1,024 | 13.5% |
| Roche Diagnostics | 587 | 7.7% |
| Roche Diabetes Care | 457 | 6% |
| Beckman Coulter | 354 | 4.7% |
| Nipro Diagnostics | 252 | 3.3% |
| Ortho-Clinical Diagnostics | 184 | 2.4% |
| Abbott Point Of Care | 156 | 2% |
| Bayer Healthcare | 143 | 1.9% |
| Nova Biomedical | 127 | 1.7% |
| Arkray | 83 | 1.1% |
| Medtronic Puerto Rico Operations | 71 | 0.9% |
| Lifescan Europe | 50 | 0.7% |
| Therasense | 41 | 0.5% |
| Lifescan Europe A Division Of Cilag Intl | 27 | 0.4% |
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 or inadequate test results | 1,188 | 15.6% |
| Incorrect, inadequate or imprecise result or readings | 935 | 12.3% |
| Unable to obtain readings | 916 | 12% |
| High test results | 788 | 10.4% |
| Replace | 782 | 10.3% |
| Computer software problema software problem | 671 | 8.8% |
| Low test results | 657 | 8.6% |
| Failure, intermittent | 476 | 6.3% |
| Wireless communication problema wireless connection problem | 339 | 4.5% |
| High readingsreadings were too high | 312 | 4.1% |
| Electrical /electronic property probleman electrical or electronic problem | 295 | 3.9% |
| Low readingsreadings were too low | 276 | 3.6% |
| False reading from device non-compliance | 223 | 2.9% |
| Device displays incorrect message | 169 | 2.2% |
| Melted | 151 | 2% |
| Other (for use when an appropriate device code cannot be identified) | 144 | 1.9% |
| Device expiration issue | 120 | 1.6% |
| Thermal decomposition of device | 99 | 1.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 75 | 1% |
| Calibration error | 61 | 0.8% |
Questions about glucose oxidase, glucose reports
What is product code CGA?
FDA's classification code for "Glucose oxidase, 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?
7,612 reports through August 2026, 55 of them in the latest 12 months.
Which brands appear most often?
Surestep (2,764), Carelink Personal Mmt-7333 (611), Accu-Chek Instant Test Strips (416), Accu-Chek Inform (277) and CardioChek Plus analyzer (218). 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.