MalfunctionDXN
TELADOC BLOOD PRESSURE MONITOR
Received Jul 16, 2026 · Event occurred Jul 1, 2026
Report 3011196194-2026-00053 · MDR key 25837946
Device
Generic name
Blood Pressure Monitor
Manufacturer
Teladoc Health, IncModel number
HT945Catalog number
OFG000010
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
52 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE RELATED TO THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INTERNAL FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED DURING FUNCTIONAL TESTING. THE INTERNAL INVESTIGATION CONFIRMED THE DEVICE WAS WORKING AS INTENDED.
Description of Event or Problem
THE PATIENT REPORTED THAT THEY COMPARED THEIR TELADOC BLOOD PRESSURE MONITOR'S READINGS TO A SIMULTANEOUS MANUAL READING PERFORMED BY A MEDICAL PROFESSIONAL. THE TELADOC MONITOR RESULT WAS 184/112, AND THE MANUAL READING RESULT WAS 110/75.
Remedial action
- Replace