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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.

46 linked reportsMalfunction 45Injury 1
24572019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 5/device2020-05: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 1 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 2/device2021-09: 2 reports for this device; peer average 1.5/device2021-10: 2 reports for this device; peer average 1.5/device2021-11: 1 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 4/device2022-01: 2 reports for this device; peer average 2/device2022-02: 1 reports for this device; peer average 1.5/device2022-03: 2 reports for this device; peer average 2.5/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2/device2022-07: 2 reports for this device; peer average 1.5/device2022-08: 3 reports for this device; peer average 3/device2022-09: 1 reports for this device; peer average 1.5/device2022-10: 2 reports for this device; peer average 2/device2022-11: 2 reports for this device; peer average 2/device2022-12: 3 reports for this device; peer average 3/device2023-01: 2 reports for this device; peer average 1.5/device2023-02: 1 reports for this device; peer average 1/device2023-03: 2 reports for this device; peer average 1.5/device2023-04: 3 reports for this device; peer average 2.5/device2023-05: 0 reports for this device; peer average 1/device2023-06: 1 reports for this device; peer average 1/device2023-07: 1 reports for this device; peer average 1/device2023-08: 1 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 2 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 2 reports for this device; peer average 2.5/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 1 reports for this device; peer average 1.33/device2024-11: 1 reports for this device; peer average 1.5/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 7/device2025-03: 2 reports for this device; peer average 1.67/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 2/device2025-07: 1 reports for this device; peer average 2.67/device2025-08: 1 reports for this device; peer average 1/device2025-10: 1 reports for this device; peer average 3/device2025-11: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 2.33/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 5/device09101112020304050710111201020304050607080910111201020304050708091011120102030405060708091011120102030405060708091011010203040507081011010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0901
2019-1003
2019-1102
2019-1201
2020-0203
2020-0302
2020-0405
2020-0501
2020-0702
2020-1001.5
2020-1103
2020-1201.5
2021-0102
2021-0201
2021-0301
2021-0401
2021-0501
2021-0601
2021-0711
2021-0802
2021-0921.5
2021-1021.5
2021-1111.5
2021-1204
2022-0122
2022-0211.5
2022-0322.5
2022-0402
2022-0502
2022-0721.5
2022-0833
2022-0911.5
2022-1022
2022-1122
2022-1233
2023-0121.5
2023-0211
2023-0321.5
2023-0432.5
2023-0501
2023-0611
2023-0711
2023-0811
2023-0901.5
2023-1021.5
2023-1101
2023-1201
2024-0102
2024-0201
2024-0322.5
2024-0401
2024-0502
2024-0601
2024-0704
2024-0801
2024-0901.5
2024-1011.33
2024-1111.5
2025-0102
2025-0207
2025-0321.67
2025-0401.5
2025-0502
2025-0712.67
2025-0811
2025-1013
2025-1102
2026-0101.5
2026-0202.33
2026-0302
2026-0402
2026-0504
2026-0605
This device (reports/month)Average device in QRL (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-10-311823260-2025-04440MalfunctionAvailableexact di
2025-08-151823260-2025-02514MalfunctionAvailableexact di
2025-07-291823260-2025-02301MalfunctionAvailableexact di
2025-03-181823260-2025-00773MalfunctionAvailableexact di
2025-03-141823260-2025-00745MalfunctionAvailableexact di
2024-11-051823260-2024-03193MalfunctionAvailableexact di
2024-10-091823260-2024-02933MalfunctionAvailableexact di
2024-03-251823260-2024-00887MalfunctionAvailableexact di
2024-03-111823260-2024-00724MalfunctionAvailableexact di
2023-10-111823260-2023-03254MalfunctionAvailableexact di
2023-10-111823260-2023-03253MalfunctionAvailableexact di
2023-08-081823260-2023-02561MalfunctionAvailableexact di
2023-07-171823260-2023-02287MalfunctionAvailableexact di
2023-06-271823260-2023-02099MalfunctionAvailableexact di
2023-04-281823260-2023-01432MalfunctionAvailableexact di
Showing 1–15 of 46
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-07-25VAIVoluntary action indicatedRoche Diabetes Care, Inc.3
2017-02-02VAIVoluntary action indicatedRoche Diabetes Care GmbH1
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