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FDA product code NBW · class 2 · Clinical Chemistry
System, test, blood glucose, over the counter: medical device reports filed with FDA
431,760 reports carry this product code, 1999–2026; 30 brands with a page.
- 431,760
- reports with this product code
- 1.7% of all MAUDE reports
- 4,756
- reports, 12 months to August 2026
- 5,188 in the 12 months before
- 90.4%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code NBW is FDA's classification for "System, test, blood glucose, over the counter" (clinical Chemistry panel), a class 2 device. 431,760 medical device reports carry this product code, 1.7% of the MAUDE database, from July 1999 to August 2026.
4,756 reports arrived in the 12 months to August 2026, close to the 5,188 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 (90.4%), injury (8.8%) 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 Europe A Division Of Cilag Intl | 223,309 | 51.7% |
| Abbott Diabetes Care | 69,001 | 16% |
| Lifescan | 52,586 | 12.2% |
| Roche Diabetes Care | 15,973 | 3.7% |
| Trividia Health | 9,962 | 2.3% |
| Roche Diagnostics | 9,450 | 2.2% |
| Bayer Healthcare | 8,825 | 2% |
| Abbott Diabetes Care USA | 6,433 | 1.5% |
| Lifescan Europe | 5,336 | 1.2% |
| Nipro Diagnostics | 3,705 | 0.9% |
| Ascensia Diabetes Care US | 3,380 | 0.8% |
| Nova Biomedical | 2,849 | 0.7% |
| Abbott Diabetes Care UK | 2,312 | 0.5% |
| Becton Dickinson | 1,729 | 0.4% |
| Mhc Medical Products | 1,577 | 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 |
|---|---|---|
| Device displays incorrect message | 103,414 | 24% |
| Failure to power up | 84,325 | 19.5% |
| Incorrect or inadequate test results | 39,745 | 9.2% |
| High test results | 26,610 | 6.2% |
| Incorrect, inadequate or imprecise result or readings | 24,178 | 5.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 19,194 | 4.4% |
| Replace | 16,192 | 3.8% |
| Loss of powerthe device lost power | 14,970 | 3.5% |
| Low test results | 10,976 | 2.5% |
| No display/image | 8,502 | 2% |
| Battery problema problem with the battery | 8,137 | 1.9% |
| Poor quality image | 6,426 | 1.5% |
| Charging problem | 5,812 | 1.3% |
| Component missing | 5,625 | 1.3% |
| Nonstandard device | 5,243 | 1.2% |
| False reading from device non-compliance | 4,612 | 1.1% |
| High readingsreadings were too high | 4,554 | 1.1% |
| Use of incorrect control/treatment settings | 4,031 | 0.9% |
| Filling problem | 3,847 | 0.9% |
| Crackthe device cracked | 3,607 | 0.8% |
Questions about system, test, blood glucose, over the counter reports
What is product code NBW?
FDA's classification code for "System, test, blood glucose, over the counter", 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?
431,760 reports through August 2026, 4,756 of them in the latest 12 months.
Which brands appear most often?
Ot Verio Iq Meter (93,039), Ot Verio2 Meter (45,294), Ot Ping Meter (37,702), Ot Ultralink Meter (25,181) and Ot Verio Flex Meter (13,501). 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.