Devices › System, test, blood glucose, over the counter
Device brand name · Blood glucose monitoring device
Accu-Chek Active: medical device reports filed with FDA
538 reports name it, 2004–2017. Manufacturer given most often on reports: Roche Diagnostics. Product code NBW.
- 538
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80.7%
- classified as malfunction
- 90.4% across the product code
- 0.4%
- classified as death, as reported
- 2 reports · not verified by FDA
538 medical device reports received by FDA name the brand "Accu-Chek Active" (blood glucose monitoring device); the manufacturer given most often on reports is Roche Diagnostics; received from January 2004 to September 2017. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (80.7%), injury (19%) and death (0.4%); across all system, test, blood glucose, over the counter reports (product code NBW) death is recorded in 0% and malfunction in 90.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (57.8%), incorrect or inadequate test results (26.8%) and false device output (22.5%). The patient problems coded most often are hospitalization required, treatment with medication(s) and therapy/non-surgical treatment, additional. 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."
Reports by month, five years
No report naming Accu-Chek Active was received in the five years to August 2026; the latest was received in September 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 431,760 reports carrying product code NBW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Replace | 311 | 57.8% | 3.8% |
| Incorrect or inadequate test results | 144 | 26.8% | 9.2% |
| False device output | 121 | 22.5% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 53 | 9.9% | 5.6% |
| Error or warning message, failure to produce | 51 | 9.5% | 0% |
| High test results | 37 | 6.9% | 6.2% |
| False reading from device non-compliance | 28 | 5.2% | 1.1% |
| Low test results | 28 | 5.2% | 2.5% |
| Output above specifications | 23 | 4.3% | 0.1% |
| Device displays incorrect message | 22 | 4.1% | 24% |
| Display or visual feedback problem | 20 | 3.7% | 0.5% |
| Labeling, missing | 16 | 3% | 0% |
| Premature system activation | 16 | 3% | 0% |
| Improper or incorrect procedure or method | 11 | 2% | 0.4% |
| Unable to obtain readings | 10 | 1.9% | 0.6% |
| Device issuea problem with the device | 9 | 1.7% | 0.1% |
| Malfunction | 7 | 1.3% | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 0.7% | 0% |
| Component missing | 3 | 0.6% | 1.3% |
| Device expiration issue | 3 | 0.6% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hospitalization required | 55 | 10.2% |
| Treatment with medication(s) | 52 | 9.7% |
| Therapy/non-surgical treatment, additional | 43 | 8% |
| Blood glucose, high | 29 | 5.4% |
| Blood glucose, low | 25 | 4.6% |
| Loss of consciousnesspassing out | 18 | 3.3% |
| Hypoglycemialow blood sugar | 13 | 2.4% |
| Hyperglycemiahigh blood sugar | 6 | 1.1% |
| Therapy/non-surgical treatment, aborted/stopped | 6 | 1.1% |
| Shaking/tremors | 5 | 0.9% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0.7% |
| Falla fall | 4 | 0.7% |
| No patient involvement | 4 | 0.7% |
| Blurred vision | 3 | 0.6% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accu-Chek Active | Product code NBW | All MAUDE reports |
|---|---|---|---|
| Reports | 538 | 431,760 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 4 | 0 | 9 |
| Classified as injury | 19% | 8.8% | 36.2% |
| Classified as malfunction | 80.7% | 90.4% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.3% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code NBW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ot Verio Iq Meter | 93,041 | 0 | 0% |
| Ot Verio2 Meter | 45,294 | 0 | 0% |
| Ot Ping Meter | 38,817 | 0 | 0% |
| Ot Ultralink Meter | 26,217 | 0 | 0% |
| Ot Verio Flex Meter | 13,503 | 0 | 0% |
| Precision Xtra | 11,696 | 6 | 0.1% |
| FreeStyle Lite | 12,244 | 430 | 0% |
| FreeStyle Freedom Lite | 11,028 | 694 | 0% |
| Neo Meter Optium FreeStyle | 10,691 | 132 | 0% |
| FreeStyle Precision Neo | 10,407 | 35 | 0% |
| Ot Verio Pro Meter | 6,716 | 0 | 0% |
| Ot Verio Test Strips | 6,351 | 0 | 0% |
| One Touch Ultralink Meter | 5,994 | 0 | 0% |
| Ot Ultra2 Meter | 5,142 | 0 | 0% |
| Ot Ping Enhanced Meter | 5,080 | 0 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Accu-Chek Active reports
How many FDA reports name Accu-Chek Active?
538 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (80.7%), injury (19%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (57.8%), incorrect or inadequate test results (26.8%), false device output (22.5%), incorrect, inadequate or imprecise result or readings (9.9%) and error or warning message, failure to produce (9.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Accu-Chek Active was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.