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.
2 linked reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 14.01 |
| 2019-02 | 0 | 19.34 |
| 2019-03 | 0 | 21.77 |
| 2019-04 | 0 | 28.26 |
| 2019-05 | 0 | 26.14 |
| 2019-06 | 0 | 24.19 |
| 2019-07 | 0 | 24.82 |
| 2019-08 | 0 | 22.58 |
| 2019-09 | 0 | 20.42 |
| 2019-10 | 0 | 22.67 |
| 2019-11 | 0 | 16.37 |
| 2019-12 | 0 | 19.89 |
| 2020-01 | 0 | 22.19 |
| 2020-02 | 0 | 18.44 |
| 2020-03 | 0 | 20.57 |
| 2020-04 | 0 | 17.63 |
| 2020-05 | 0 | 24.77 |
| 2020-06 | 0 | 30.27 |
| 2020-07 | 0 | 18.51 |
| 2020-08 | 0 | 12.33 |
| 2020-09 | 0 | 19.58 |
| 2020-10 | 0 | 12.45 |
| 2020-11 | 0 | 18.13 |
| 2020-12 | 0 | 18.98 |
| 2021-01 | 0 | 16.35 |
| 2021-02 | 0 | 17.07 |
| 2021-03 | 0 | 18.21 |
| 2021-04 | 0 | 19.62 |
| 2021-05 | 0 | 20 |
| 2021-06 | 0 | 19.7 |
| 2021-07 | 0 | 28.06 |
| 2021-08 | 0 | 17.13 |
| 2021-09 | 0 | 21.17 |
| 2021-10 | 0 | 19.14 |
| 2021-11 | 0 | 16.63 |
| 2021-12 | 0 | 23.6 |
| 2022-01 | 0 | 16.23 |
| 2022-02 | 0 | 15.33 |
| 2022-03 | 0 | 17.98 |
| 2022-04 | 0 | 16.62 |
| 2022-05 | 0 | 18.6 |
| 2022-06 | 0 | 14.8 |
| 2022-07 | 0 | 14.55 |
| 2022-08 | 0 | 8 |
| 2022-09 | 0 | 9.32 |
| 2022-10 | 0 | 8.08 |
| 2022-11 | 0 | 11.65 |
| 2022-12 | 0 | 7.24 |
| 2023-01 | 0 | 13.11 |
| 2023-02 | 0 | 9.6 |
| 2023-03 | 0 | 9.9 |
| 2023-04 | 0 | 7.78 |
| 2023-05 | 0 | 36.62 |
| 2023-06 | 0 | 23.03 |
| 2023-07 | 0 | 13.17 |
| 2023-08 | 0 | 11.24 |
| 2023-09 | 0 | 6.48 |
| 2023-10 | 0 | 6.48 |
| 2023-11 | 0 | 4.73 |
| 2023-12 | 0 | 4.39 |
| 2024-01 | 0 | 8.58 |
| 2024-02 | 0 | 2.73 |
| 2024-03 | 0 | 7.97 |
| 2024-04 | 0 | 4.02 |
| 2024-05 | 0 | 7.3 |
| 2024-06 | 0 | 5.13 |
| 2024-07 | 0 | 3.64 |
| 2024-08 | 0 | 3.3 |
| 2024-09 | 0 | 3.83 |
| 2024-10 | 0 | 4.44 |
| 2024-11 | 0 | 2.81 |
| 2024-12 | 0 | 5.57 |
| 2025-01 | 0 | 5.49 |
| 2025-02 | 0 | 2.66 |
| 2025-03 | 0 | 2.86 |
| 2025-04 | 0 | 3.69 |
| 2025-05 | 0 | 4.88 |
| 2025-06 | 0 | 3.09 |
| 2025-07 | 0 | 3.13 |
| 2025-08 | 0 | 4.73 |
| 2025-09 | 0 | 2.75 |
| 2025-10 | 0 | 3.59 |
| 2025-11 | 0 | 3.6 |
| 2025-12 | 0 | 2.64 |
| 2026-01 | 0 | 4.2 |
| 2026-02 | 1 | 2.35 |
| 2026-03 | 0 | 3.51 |
| 2026-04 | 0 | 3.03 |
| 2026-05 | 0 | 3.02 |
| 2026-06 | 1 | 4.17 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-05-13 | Z-2174-2024 | Class II | Open, Classified | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.Distribution: Nationwide and Worldwide | 48 units | clearance family |
| 2019-09-30 | Z-0747-2020 | Class II | Terminated | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.Distribution: US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA. | 318,678 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-17 | 3011393376-2026-00376 | Malfunction | Available | exact di |
| 2026-02-13 | 3011393376-2026-00113 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K160944Substantially equivalent (SESE) · 2016-08-31clearance family
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 |
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