FDA Adverse Event
Malfunction
Summary report: N
TELADOC BLOOD PRESSURE MONITOR
MDR report key: 25164480
·
Received May 13, 2026
Report
- Report Number
- 3011196194-2026-00033
- Event Type
- Malfunction
- Date Received
- May 13, 2026
- Date of Event
- April 16, 2026
- Report Date
- May 12, 2026
- Manufacturer
- TELADOC HEALTH, INC.
- Product Code
- DXN
- PMA / PMN Number
- K202891
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THEY COMPARED THEIR TELADOC MONITOR TO A SIMULTANEOUS MANUAL READING PERFORMED BY A MEDICAL PROFESSIONAL. THE TELADOC MONITOR DISPLAYED A READING OF 138/93, WHEREAS THE MANUAL READING WAS 114/80. THE PATIENT MENTIONED THEIR MEDICATION WAS CHANGED TO ANOTHER MEDICINE AND THAT THE CHANGE OCCURRED AFTER THE MANUAL READING WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108531 | TELADOC BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH, INC. | HT945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Unknown | Other |