TELADOC BLOOD PRESSURE MONITOR
Report
- Report Number
- 3011196194-2025-00096
- Event Type
- Malfunction
- Date Received
- November 3, 2025
- Date of Event
- September 30, 2025
- Report Date
- December 1, 2025
- Manufacturer
- TELADOC HEALTH, INC
- Product Code
- DXN
- PMA / PMN Number
- K202891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
A REPLACEMENT BLOOD PRESSURE MONITOR WAS SENT. 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.
THE PATIENT REPORTED THAT THEY COMPARED THEIR TELADOC MONITOR TO A SIMULTANEOUS MANUAL READING PERFORMED BY A MEDICAL PROFESSIONAL AND THE RESULTS WERE GREATER THAN 20MMHG. THE TELADOC MONITOR DISPLAYED A READING OF 124/78, WHEREAS THE MANUAL READING WAS 101/70. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT AS PART OF THE DEVICE MALFUNCTION.
THE PATIENT REPORTED THAT THEY COMPARED THEIR TELADOC MONITOR TO A SIMULTANEOUS MANUAL READING PERFORMED BY A MEDICAL PROFESSIONAL AND THE RESULTS WERE GREATER THAN 20MMHG. THE TELADOC MONITOR DISPLAYED A READING OF 124/78, WHEREAS THE MANUAL READING WAS 101/70. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT AS PART OF THE DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1019538 | TELADOC BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH, INC | HT945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Unknown |