Devices › System, test, blood glucose, over the counter
Device brand name · Blood glucose monitoring system
FreeStyle Insulinx: medical device reports filed with FDA
2,426 reports name it, 2012–2026. Manufacturer given most often on reports: Abbott Diabetes Care. Product code NBW.
- 2,426
- device reports naming the brand
- 0% of all MAUDE reports · about 169 a year
- 16
- reports, 12 months to August 2026
- 13 in the 12 months before
- 94.4%
- classified as malfunction
- 90.4% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 2,426 reports that name the brand "FreeStyle Insulinx" (blood glucose monitoring system), received between March 2012 and July 2026; the manufacturer given most often on reports is Abbott Diabetes Care. Spellings of one product vary from report to report.
16 reports arrived in the 12 months to August 2026, up 23% from 13 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 (94.4%) and injury (5.6%); 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 failure to power up (89.9%), incorrect, inadequate or imprecise result or readings (2.6%) and incorrect or inadequate test results (2.1%). The patient problems coded most often are hypoglycemia, hyperglycemia and loss of consciousness. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Failure to power up | 2,182 | 89.9% | 19.5% |
| Incorrect, inadequate or imprecise result or readings | 62 | 2.6% | 5.6% |
| Incorrect or inadequate test results | 51 | 2.1% | 9.2% |
| Device displays incorrect message | 14 | 0.6% | 24% |
| High readingsreadings were too high | 13 | 0.5% | 1.1% |
| High test results | 13 | 0.5% | 6.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 12 | 0.5% | 4.4% |
| False reading from device non-compliance | 12 | 0.5% | 1.1% |
| No display/image | 10 | 0.4% | 2% |
| Unable to obtain readings | 10 | 0.4% | 0.6% |
| Low test results | 8 | 0.3% | 2.5% |
| Nonstandard device | 6 | 0.2% | 1.2% |
| Low readingsreadings were too low | 5 | 0.2% | 0.3% |
| No device output | 5 | 0.2% | 0.1% |
| Battery problema problem with the battery | 4 | 0.2% | 1.9% |
| Loss of powerthe device lost power | 4 | 0.2% | 3.5% |
| Crackthe device cracked | 3 | 0.1% | 0.8% |
| Insufficient device problem information | 3 | 0.1% | 0.8% |
| Calibration problem | 2 | 0.1% | 0% |
| Human-device interface problem | 2 | 0.1% | 0% |
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 |
|---|---|---|
| Hypoglycemialow blood sugar | 56 | 2.3% |
| Hyperglycemiahigh blood sugar | 54 | 2.2% |
| Loss of consciousnesspassing out | 35 | 1.4% |
| Dizzinesslight-headedness or unsteadiness | 20 | 0.8% |
| Shaking/tremors | 20 | 0.8% |
| Sweating | 20 | 0.8% |
| Elevated ketones/ diabetic ketoacidosis | 15 | 0.6% |
| Seizures | 11 | 0.5% |
| Confusion/ disorientation | 10 | 0.4% |
| Vomitingbeing sick | 9 | 0.4% |
| Headachehead pain | 7 | 0.3% |
| Blurred vision | 6 | 0.2% |
| Complaint, ill-defined | 6 | 0.2% |
| Nauseafeeling sick | 6 | 0.2% |
| Dehydrationdehydration | 5 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | FreeStyle Insulinx | Product code NBW | All MAUDE reports |
|---|---|---|---|
| Reports | 2,426 | 431,760 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 5.6% | 8.8% | 36.2% |
| Classified as malfunction | 94.4% | 90.4% | 62.3% |
| Filed by the manufacturer | 100% | 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 FreeStyle Insulinx reports
How many FDA reports name FreeStyle Insulinx?
2,426 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.
What kinds of events are reported?
malfunction (94.4%) and injury (5.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to power up (89.9%), incorrect, inadequate or imprecise result or readings (2.6%), incorrect or inadequate test results (2.1%), device displays incorrect message (0.6%) and high readings (0.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that FreeStyle Insulinx 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.