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TRUEtrackRecalls & reported problems across all models

Trividia Health, Inc. · 21 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
445
Deaths reported
0
Injuries reported
15
Recalls
0

We found 21 models of TRUEtrack by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 445 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Aug 8, 2023 — classified as 15 injuries, 430 malfunctions.

The most frequently reported specific device problem is “High Test Results” (265 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUEtrack problems

Device problems

  • High Test Results265
  • Low Test Results76
  • Device Displays Incorrect Message48
  • Incorrect Or Inadequate Test Results20
  • Image Display Error/Artifact9
  • Incorrect, Inadequate or Imprecise Result or Readings9
  • Battery Problem8
  • Incomplete or Missing Packaging7

Patient problems

  • No Known Impact Or Consequence To Patient248
  • No Consequences Or Impact To Patient45
  • Fatigue23
  • Dizziness21
  • Polydipsia21
  • Urinary Frequency / Polyuria19
  • Weakness17
  • Blurred Vision16

TRUEtrack models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent TRUEtrack adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Trividia Health, Inc. products

All Trividia Health, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page