TELADOC BLOOD PRESSURE MONITOR
Received May 20, 2026 · Event occurred Apr 29, 2026
Report 3011196194-2026-00038 · MDR key 25229982
Device
Generic name
Blood Pressure Monitor
Manufacturer
Teladoc Health, Inc.Model number
HT900Catalog number
OFG06546
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Output Problem
Patient
55 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 HAS NOT BEEN PERFORMED YET.
Description of Event or Problem
THE MEMBER REPORTED AN ACCURACY CONCERN WITH THEIR TELADOC HEALTH BLOOD PRESSURE MONITOR. THE MEMBER REPORTED THAT THEY WERE EXPERIENCING ISSUES REGARDING COMPARING MONITORS. MEMBER SUPPORT EDUCATED THE MEMBER ON PROPER TECHNIQUE AND USAGE AND ELIMINATED EXTERNAL FACTORS. WE CONFIRMED THAT THE MEMBER'S ARM IS WITHIN THE CORRECT CUFF CIRCUMFERENCE. THE MEMBER COMPARED THEIR TELADOC BLOOD PRESSURE MONITOR READING WITH A MANUAL READING TAKEN AT THEIR DOCTOR'S OFFICE. BOTH READINGS WERE COMPLETED SIMULTANEOUSLY. THE TELADOC MONITOR RECORDED A READING OF 166/97, WHILE THE MANUAL READINGS OBTAINED AT THE DOCTOR'S OFFICE WERE 130/89 & 134/96, REFLECTING A VARIANCE GREATER THAN 20 MMHG. MEMBER SUPPORT PLACED AN ORDER FOR A REPLACEMENT DEVICE AND THE MEMBER SENT BACK THE ORIGINAL DEVICE FOR TESTING.
Remedial action
- Replace