FDA Adverse Event
Malfunction
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 17646608
·
Received August 29, 2023
Report
- Report Number
- 3011196194-2023-00075
- Event Type
- Malfunction
- Date Received
- August 29, 2023
- Date of Event
- July 27, 2023
- Report Date
- August 29, 2023
- Manufacturer
- TELADOC HEALTH INC.
- Product Code
- DXN
- PMA / PMN Number
- K131395
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS DETERMINED THAT THE INACCURATE READINGS AND BRUISING THAT THE PATIENT REPORTED WERE DUE TO THE CUFF BEING TOO SMALL FOR THE PATIENTS ARM. THE DEVICE ASSOCIATED WITH THIS IINCIDENT WAS NOT RETURNED FOR INVESTIGATION. SHOULD THE DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED TO DDOCUMENT THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 0
PATIENT REPORTED THAT THE MONITOR IS GIVING INACCURATE READINGS, AND ALSO CAUSE BRUISING DUE TO THE CUFF BEING TOO SMALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2222359 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | DXN | TELADOC HEALTH INC. | HT900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Other |