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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.

6 linked reportsMalfunction 6
23562019-01: 0 reports for this device; peer average 2/device2019-08: 1 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2022-04: 1 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 6/device2023-11: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-05: 1 reports for this device; peer average 1.33/device2025-12: 3 reports for this device; peer average 3/device0108091012040204061103020512
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0811
2019-0901
2019-1001
2019-1201
2020-0401
2021-0202
2022-0411
2022-0606
2023-1106
2024-0302
2025-0202
2025-0511.33
2025-1233
This device (reports/month)Average device in KLT (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-12-021823260-2025-04912MalfunctionAvailablecatalog number
2025-05-291823260-2025-01645MalfunctionAvailableprocode brand trgm
2022-04-141823260-2022-01041MalfunctionAvailableprocode brand trgm
2019-08-071823260-2019-02868MalfunctionAvailableprocode brand trgm

Showing the most recent 4 of 6 linked reports.

Regulatory clearances
  • 510(k)K151578Substantially equivalent (SESE) · 2015-10-22clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-08-29VAIVoluntary action indicatedRoche Diagnostics GmbH0
2018-04-19NAINo action indicatedRoche Diagnostics GmbH0
2018-04-12NAINo action indicatedRoche Diagnostics GmbH0
2016-11-18NAINo action indicatedRoche Diagnostics GmbH0
2015-05-27NAINo action indicatedRoche Diagnostics GmbH0
2015-05-20NAINo action indicatedRoche Diagnostics GmbH0
2013-12-18NAINo action indicatedRoche Diagnostics GmbH0
2012-09-27NAINo action indicatedRoche Diagnostics GmbH0
2012-09-20NAINo action indicatedRoche Diagnostics GmbH0
2011-02-17NAINo action indicatedRoche Diagnostics GmbH0
2011-02-15NAINo action indicatedRoche Diagnostics GmbH0
2011-02-10NAINo action indicatedRoche Diagnostics GmbH0
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