FDA Adverse Event
Malfunction
Summary report: N
TELADOC BLOOD PRESSURE MONITOR
MDR report key: 23818436
·
Received December 16, 2025
Report
- Report Number
- 3011196194-2025-00111
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- December 2, 2025
- Report Date
- December 11, 2025
- Manufacturer
- TELADOC HEALTH, INC.
- Product Code
- DXN
- PMA / PMN Number
- K202891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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 · 0
THE PATIENT COMPARED THEIR READINGS FROM THE TELADOC HEALTH BLOOD PRESSURE MONITOR WITH THEIR DOCTOR'S MANUAL DEVICE. MEASUREMENTS WERE TAKEN SIMULTANEOUSLY, AND THE DIFFERENCE BETWEEN THE READINGS WAS GREATER THAN 20 MMHG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2205948 | TELADOC BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH, INC. | HT945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown |