Devices › Glucose oxidase, glucose
Device brand name · Blood glucose meter
Ascensia Breeze: medical device reports filed with FDA
194 reports name it, 2004–2009. Manufacturer given most often on reports: Bayer Healthcare. Product code CGA.
- 194
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 73.2%
- classified as malfunction
- 91% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
194 medical device reports received by FDA name the brand "Ascensia Breeze" (blood glucose meter); the manufacturer given most often on reports is Bayer Healthcare; received from March 2004 to August 2009. 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 (73.2%), injury (22.2%) and other (4.1%); across all glucose oxidase, glucose reports (product code CGA) death is recorded in 0.2% and malfunction in 91%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (44.8%), incorrect or inadequate test results (30.9%) and high test results (22.7%). The patient problems coded most often are hospitalization required, blood glucose, low and blood glucose, high. 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 Ascensia Breeze was received in the five years to August 2026; the latest was received in August 2009.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 7,612 reports carrying product code CGA. 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 | 87 | 44.8% | 10.3% |
| Incorrect or inadequate test results | 60 | 30.9% | 15.6% |
| High test results | 44 | 22.7% | 10.4% |
| Use of incorrect control/treatment settings | 34 | 17.5% | 0.4% |
| Incorrect measurementthe device measured wrongly | 13 | 6.7% | 0.2% |
| No display/image | 12 | 6.2% | 0.5% |
| Device displays incorrect message | 11 | 5.7% | 2.2% |
| Low test results | 7 | 3.6% | 8.6% |
| Component missing | 6 | 3.1% | 0.4% |
| High readingsreadings were too high | 6 | 3.1% | 4.1% |
| Repair | 6 | 3.1% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 2.6% | 1.9% |
| Device expiration issue | 3 | 1.5% | 1.6% |
| Display or visual feedback problem | 3 | 1.5% | 0.2% |
| Failure to power up | 2 | 1% | 0.7% |
| Incorrect software programming calculations | 2 | 1% | 0% |
| Low readingsreadings were too low | 2 | 1% | 3.6% |
| Battery failure | 1 | 0.5% | 0% |
| Bent | 1 | 0.5% | 0% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.5% | 12.3% |
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 | 26 | 13.4% |
| Blood glucose, low | 18 | 9.3% |
| Blood glucose, high | 12 | 6.2% |
| Therapy/non-surgical treatment, additional | 11 | 5.7% |
| Treatment with medication(s) | 11 | 5.7% |
| Hypoglycemialow blood sugar | 5 | 2.6% |
| Loss of consciousnesspassing out | 5 | 2.6% |
| Elevated ketones/ diabetic ketoacidosis | 3 | 1.5% |
| Falla fall | 3 | 1.5% |
| Collapse | 1 | 0.5% |
| Comatose | 1 | 0.5% |
| Convulsion | 1 | 0.5% |
| Fainting | 1 | 0.5% |
| Fatiguetiredness | 1 | 0.5% |
| Hyperglycemiahigh blood sugar | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ascensia Breeze | Product code CGA | All MAUDE reports |
|---|---|---|---|
| Reports | 194 | 7,612 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 5 | 2 | 9 |
| Classified as injury | 22.2% | 7.8% | 36.2% |
| Classified as malfunction | 73.2% | 91% | 62.3% |
| Filed by the manufacturer | 100% | 98.2% | 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 CGA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Surestep | 5,323 | 0 | 0.1% |
| Carelink Personal Mmt-7333 | 3,680 | 233 | 0% |
| Accu-Chek Instant Test Strips | 421 | 0 | 0% |
| Accu-Chek Inform | 775 | 0 | 0.1% |
| CardioChek Plus analyzer | 218 | 7 | 0% |
| Truetrack | 1,652 | 0 | 0% |
| Vitros Chemistry Products Glu Slides | 192 | 3 | 0% |
| Sftwr Css7201 Guardian Android App | 955 | 2 | 0% |
| Software Css7200 Grdn Ios App | 1,099 | 2 | 0% |
| Unicel Dxc 800 Pro Synchron Chemistry Analyzer | 898 | 0 | 0% |
| Accu-Chek Advantage | 1,290 | 0 | 0.5% |
| Paradigm Real-Time Insulin Infusion Pump | 126,282 | 0 | 0.3% |
| Accu-Chek Instant | 416 | 183 | 0% |
| Unicel Dxc 800 Synchron System | 2,232 | 0 | 0% |
| Unicel Dxc 800 Pro Synchron Clinical System | 408 | 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 Ascensia Breeze reports
How many FDA reports name Ascensia Breeze?
194 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 (73.2%), injury (22.2%) and other (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (44.8%), incorrect or inadequate test results (30.9%), high test results (22.7%), use of incorrect control/treatment settings (17.5%) and incorrect measurement (6.7%). 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 Ascensia Breeze 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.