Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
17 linked reportsMalfunction 9Injury 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 8.87 |
| 2019-02 | 0 | 10 |
| 2019-03 | 0 | 9.14 |
| 2019-04 | 0 | 13.35 |
| 2019-05 | 0 | 11.61 |
| 2019-06 | 0 | 11.16 |
| 2019-07 | 0 | 11.37 |
| 2019-08 | 0 | 11.23 |
| 2019-09 | 1 | 9.05 |
| 2019-10 | 2 | 9.22 |
| 2019-11 | 1 | 7.09 |
| 2019-12 | 0 | 5.97 |
| 2020-01 | 5 | 8.74 |
| 2020-02 | 0 | 7.36 |
| 2020-03 | 0 | 7.88 |
| 2020-04 | 0 | 7.33 |
| 2020-05 | 0 | 8.65 |
| 2020-06 | 2 | 8.05 |
| 2020-07 | 1 | 6.97 |
| 2020-08 | 0 | 4.44 |
| 2020-09 | 1 | 9.55 |
| 2020-10 | 0 | 5.03 |
| 2020-11 | 1 | 7.15 |
| 2020-12 | 1 | 7.11 |
| 2021-01 | 0 | 9.11 |
| 2021-02 | 0 | 7.95 |
| 2021-03 | 0 | 7.12 |
| 2021-04 | 0 | 8.16 |
| 2021-05 | 0 | 5.87 |
| 2021-06 | 0 | 7.26 |
| 2021-07 | 0 | 8.31 |
| 2021-08 | 0 | 8.96 |
| 2021-09 | 0 | 8.24 |
| 2021-10 | 0 | 8.24 |
| 2021-11 | 0 | 8.87 |
| 2021-12 | 0 | 9.97 |
| 2022-01 | 0 | 8.46 |
| 2022-02 | 0 | 7.61 |
| 2022-03 | 0 | 9.07 |
| 2022-04 | 0 | 8.69 |
| 2022-05 | 0 | 7.15 |
| 2022-06 | 0 | 6.51 |
| 2022-07 | 1 | 7.8 |
| 2022-08 | 0 | 3.58 |
| 2022-09 | 0 | 4.01 |
| 2022-10 | 0 | 3.88 |
| 2022-11 | 0 | 8.03 |
| 2022-12 | 0 | 3.85 |
| 2023-01 | 0 | 6.97 |
| 2023-02 | 0 | 5.46 |
| 2023-03 | 0 | 4.71 |
| 2023-04 | 0 | 2.97 |
| 2023-05 | 0 | 4.28 |
| 2023-06 | 0 | 3.85 |
| 2023-07 | 0 | 3.28 |
| 2023-08 | 0 | 4.91 |
| 2023-09 | 0 | 2.62 |
| 2023-10 | 0 | 2.92 |
| 2023-11 | 0 | 2.86 |
| 2023-12 | 0 | 2.54 |
| 2024-01 | 0 | 5.41 |
| 2024-02 | 0 | 2.44 |
| 2024-03 | 0 | 5.41 |
| 2024-04 | 0 | 3.01 |
| 2024-05 | 0 | 4.45 |
| 2024-06 | 0 | 3.52 |
| 2024-07 | 0 | 2.43 |
| 2024-08 | 1 | 2.34 |
| 2024-09 | 0 | 2.97 |
| 2024-10 | 0 | 3.97 |
| 2024-11 | 0 | 2.4 |
| 2024-12 | 0 | 4.28 |
| 2025-01 | 0 | 5.77 |
| 2025-02 | 0 | 2.22 |
| 2025-03 | 0 | 2.47 |
| 2025-04 | 0 | 4.3 |
| 2025-05 | 0 | 5.09 |
| 2025-06 | 0 | 2.26 |
| 2025-07 | 0 | 2.06 |
| 2025-08 | 0 | 4.08 |
| 2025-09 | 0 | 2.55 |
| 2025-10 | 0 | 3.37 |
| 2025-11 | 0 | 3.2 |
| 2025-12 | 0 | 3.83 |
| 2026-01 | 0 | 4.64 |
| 2026-02 | 0 | 2.34 |
| 2026-03 | 0 | 5.13 |
| 2026-04 | 0 | 5.43 |
| 2026-05 | 0 | 4.09 |
| 2026-06 | 0 | 6.93 |
Failure-mode summaryAI-generated
17 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-08-06 | 3011393376-2024-01656 | Injury | Available | exact di |
| 2022-07-27 | 3011393376-2022-02249 | Malfunction | Available | exact di |
| 2020-12-22 | 3011393376-2020-04595 | Malfunction | Available | exact di |
| 2020-11-10 | 3011393376-2020-04060 | Malfunction | Available | exact di |
| 2020-09-11 | 3011393376-2020-03255 | Injury | Available | exact di |
| 2020-07-30 | 3011393376-2020-02732 | Malfunction | Available | exact di |
| 2020-06-29 | 3011393376-2020-02244 | Malfunction | Available | exact di |
| 2020-06-12 | 3011393376-2020-02059 | Malfunction | Available | exact di |
| 2020-01-29 | 3011393376-2020-00318 | Injury | Available | exact di |
| 2020-01-29 | 3011393376-2020-00317 | Injury | Available | exact di |
| 2020-01-16 | 3011393376-2020-00163 | Injury | Available | exact di |
| 2020-01-15 | 3011393376-2020-00153 | Injury | Available | exact di |
| 2020-01-14 | 3011393376-2020-00125 | Injury | Available | exact di |
| 2019-11-22 | 3011393376-2019-04301 | Malfunction | Available | exact di |
| 2019-10-25 | 3011393376-2019-03997 | Malfunction | Available | exact di |
Showing 1–15 of 17
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-11-30 | NAI | No action indicated | Roche Molecular Systems, Inc. | 0 |
| 2022-12-07 | NAI | No action indicated | Roche Diagnostics Operations, Inc. | 0 |
| 2022-09-23 | NAI | No action indicated | Ventana Medical Systems, Inc. | 0 |
| 2022-09-15 | NAI | No action indicated | Ventana Medical Systems, Inc. | 0 |
| 2021-07-29 | NAI | No action indicated | Ventana Medical Systems, Inc. | 0 |
| 2020-02-26 | NAI | No action indicated | Ventana Medical Systems, Inc. | 0 |
| 2019-08-29 | VAI | Voluntary action indicated | Roche Diagnostics GmbH | 0 |
| 2019-08-14 | NAI | No action indicated | Ventana Medical Systems, Inc. | 0 |
| 2019-07-25 | VAI | Voluntary action indicated | Roche Diabetes Care, Inc. | 3 |
| 2019-06-27 | VAI | Voluntary action indicated | Roche Diagnostics Operations, Inc. | 1 |
| 2018-04-19 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2018-04-12 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2017-07-24 | NAI | No action indicated | Roche Molecular Systems, Inc. | 0 |
| 2017-07-13 | NAI | No action indicated | Ventana Medical Systems, Inc. | 0 |
| 2017-02-27 | NAI | No action indicated | Roche Molecular Systems, Inc. | 0 |
| 2017-02-02 | VAI | Voluntary action indicated | Roche Diabetes Care GmbH | 1 |
| 2016-11-18 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2016-10-14 | NAI | No action indicated | Roche Diagnostics Operations, Inc. | 0 |
| 2016-09-01 | NAI | No action indicated | Roche Molecular Systems, Inc. | 0 |
| 2016-08-15 | VAI | Voluntary action indicated | Roche Diagnostics Operations, Inc. | 1 |
Similar devices
- ABOUND® ASCENSIA DIABETES CARE US INC.
- ABOUND® ASCENSIA DIABETES CARE US INC.
- Accu-Chek Compact Plus Roche Diabetes Care GmbH
- Accu-Chek Compact Plus Roche Diabetes Care GmbH
- Accu-Chek Compact Plus Roche Diabetes Care GmbH
- Accu-Chek Compact Plus Roche Diabetes Care GmbH
- Accu-Chek Compact Plus Roche Diabetes Care GmbH
- BLE Smart Test Strip ENTRA HEALTH SYSTEMS LLC
- BLE Smart® Test Strips ENTRA HEALTH SYSTEMS LLC
- Blood Glucose Test Strips (50pcs/box) LIVE TULA TULA HEALTH, INC.
- Bruno BRUNO PHARMA INNOVATIONS, LLC
- Bruno BRUNO PHARMA INNOVATIONS, LLC
Select up to two to place side-by-side with this device.