Device: Diagnostic
55 adverse event reports submitted to the FDA
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Data Summary
| Metric | Value |
|---|---|
| Total adverse event reports | 55 |
| Reports involving death | 0 |
| Case-fatality rate (reported events) | 0.0% |
| Distinct species in reports | 2 |
| Distinct breeds in reports | 1 |
| Distinct reactions reported | 8 |
| Active ingredients on file | 1 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.
Device: Diagnostic Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 55 adverse event reports referencing Device: Diagnostic, including 0 reports in which the animal died — a 0.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Device: Diagnostic. Reported administration route is Unknown. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.
The species most frequently named in Device: Diagnostic reports are Unknown (54 reports), Human (1 reports), with Unknown accounting for the largest share. Within those species, Unknown (55) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.
The most commonly reported clinical signs associated with Device: Diagnostic are Device Defective NOS (26), Product Defect, General (17), Lack of efficacy, medical device (6), Broken components, medical device (3). Of the 2 reports with a coded outcome, Outcome Unknown is the leading category at 100.0%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Device: Diagnostic.
Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates
Read our methodology — how this data is sourced, computed, and verified.