Devices › Glucose dehydrogenase, glucose
Device brand name · Blood glucose monitoring test strips
Accu-Chek Aviva Test Strips: medical device reports filed with FDA
11,073 reports name it, 2005–2024. Manufacturer given most often on reports: Roche Diagnostics. Product code LFR.
- 11,073
- device reports naming the brand
- 0% of all MAUDE reports · about 532 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 96.3%
- classified as malfunction
- 93% across the product code
- 0%
- classified as death, as reported
- 2 reports · not verified by FDA
11,073 medical device reports received by FDA name the brand "Accu-Chek Aviva Test Strips" (blood glucose monitoring test strips); the manufacturer given most often on reports is Roche Diagnostics; received from September 2005 to September 2024. 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, against 2 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 (96.3%) and injury (3.7%); across all glucose dehydrogenase, glucose reports (product code LFR) death is recorded in 0% and malfunction in 93%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (68.9%), incorrect or inadequate test results (28.2%) and replace (4.1%). The patient problems coded most often are hypoglycemia, hyperglycemia 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
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 74,282 reports carrying product code LFR. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 7,626 | 68.9% | 33.5% |
| Incorrect or inadequate test results | 3,128 | 28.2% | 25.8% |
| Replace | 455 | 4.1% | 6% |
| Improper device output | 269 | 2.4% | 1.5% |
| Expiration date error | 93 | 0.8% | 0.3% |
| Device expiration issue | 81 | 0.7% | 0.7% |
| Device markings/labelling problema problem with the device markings or label | 81 | 0.7% | 0.2% |
| Mislabeled | 77 | 0.7% | 0.5% |
| Insufficient device problem information | 72 | 0.7% | 0.3% |
| High test results | 52 | 0.5% | 4% |
| Improper or incorrect procedure or method | 35 | 0.3% | 0.4% |
| Measurements, inaccurate | 33 | 0.3% | 0.4% |
| Unable to obtain readings | 30 | 0.3% | 0.2% |
| Device displays incorrect message | 28 | 0.3% | 3.8% |
| Other (for use when an appropriate device code cannot be identified) | 26 | 0.2% | 0.5% |
| Shelf life exceeded | 25 | 0.2% | 0.1% |
| Low test results | 9 | 0.1% | 1.6% |
| Imprecise or erratic results | 5 | 0% | 1% |
| Non reproducible results | 3 | 0% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 3 | 0% | 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 | 649 | 5.9% |
| Hyperglycemiahigh blood sugar | 110 | 1% |
| Therapy/non-surgical treatment, additional | 47 | 0.4% |
| Loss of consciousnesspassing out | 46 | 0.4% |
| Aneurysm | 31 | 0.3% |
| Treatment with medication(s) | 25 | 0.2% |
| Blood glucose, low | 18 | 0.2% |
| Sweating | 18 | 0.2% |
| Other (for use when an appropriate patient code cannot be identified) | 17 | 0.2% |
| Hospitalization required | 13 | 0.1% |
| Elevated ketones/ diabetic ketoacidosis | 12 | 0.1% |
| Dizzinesslight-headedness or unsteadiness | 9 | 0.1% |
| Seizures | 9 | 0.1% |
| Confusion/ disorientation | 8 | 0.1% |
| Shaking/tremors | 8 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accu-Chek Aviva Test Strips | Product code LFR | All MAUDE reports |
|---|---|---|---|
| Reports | 11,073 | 74,282 | 26,136,888 |
| Share of that pool | — | 14.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 3.7% | 6.9% | 36.2% |
| Classified as malfunction | 96.3% | 93% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 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 LFR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Freestyle Flash | 19,422 | 0 | 0% |
| Accu-Chek Comfort Curve Test Strips | 13,065 | 0 | 0% |
| Accu-Chek Compact Test Drum | 7,579 | 0 | 0% |
| Freestyle | 9,490 | 26 | 0.1% |
| Accu-Chek Aviva Plus Test Strips | 7,947 | 0 | 0% |
| Accu-Chek Mobile Test Strips | 3,527 | 0 | 0% |
| Accu-Chek Performa Test Strips | 3,886 | 1 | 0% |
| Accu-Chek Active Test Strips | 1,475 | 0 | 0% |
| Accu-Chek Comfort Curve | 4,120 | 0 | 0.6% |
| FreeStyle Lite | 12,244 | 430 | 0% |
| Freestyle Freedom | 3,430 | 6 | 0% |
| Accu-Chek Guide | 772 | 365 | 0% |
| Accu-Chek Smartview Test Strips | 993 | 0 | 0% |
| Freestyle Navigator | 754 | 0 | 0% |
| Accu-Chek Compact Plus Test Drum | 769 | 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 Aviva Test Strips reports
How many FDA reports name Accu-Chek Aviva Test Strips?
11,073 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 (96.3%) and injury (3.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (68.9%), incorrect or inadequate test results (28.2%), replace (4.1%), improper device output (2.4%) and expiration date error (0.8%). 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 Accu-Chek Aviva Test Strips 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.