FDA Adverse Event
Malfunction
Summary report: N
LIVONGO BLOOD PRESSURE MONITOR
MDR report key: 20100609
·
Received August 29, 2024
Report
- Report Number
- 3011196194-2024-00044
- Event Type
- Malfunction
- Date Received
- August 29, 2024
- Date of Event
- August 12, 2024
- Report Date
- August 29, 2024
- 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 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 THEIR MONITOR WAS SMOKING. TELADOC HEALTH CONTACTED THE MEMBER FOR ADDITIONAL INFORMATION, BUT IT WAS UNSUCCESSFUL. THE PATIENT DIDN'T CONFIRM IF MEDICAL ATTENTION OR TREATMENT WAS PROVIDED AS PART OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1522276 | LIVONGO BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH, INC. | HT900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Unknown |