FDA Adverse Event
Malfunction
Summary report: N
TELEDOC BLOOD PRESSURE MONITOR
MDR report key: 25104580
·
Received May 6, 2026
Report
- Report Number
- 3011196194-2026-00030
- Event Type
- Malfunction
- Date Received
- May 6, 2026
- Date of Event
- April 20, 2026
- Report Date
- April 27, 2026
- Manufacturer
- TELADOC HEALTH INC
- Product Code
- DXN
- PMA / PMN Number
- K131395
- 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 PAITENT REPORTED INACCURATE READINGS FROM THEIR TELADOC BLOOD PRESSURE MONITOR. THE TELADOC MONITOR READINGS WERE APPROXIMATELY 20 POINTS HIGHER WHEN COMPARED TO READINGS OBTAINED USING THE DOCTOR'S MANUAL PUMP MONITOR. THE MEASUREMENTS WERE TAKEN 1-3 MINUTES APART. NO MEDICAL TREATMENT WAS REPORTED IN CONNECTION WITH THE DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176957 | TELEDOC BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH INC | HT900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female |