FDA Adverse Event
Injury
Summary report: N
LIVONGO LANCING DEVICE
MDR report key: 19806026
·
Received July 23, 2024
Report
- Report Number
- 3011196194-2024-00035
- Event Type
- Injury
- Date Received
- July 23, 2024
- Date of Event
- July 1, 2024
- Report Date
- July 22, 2024
- Manufacturer
- TELADOC HEALTH INC.
- Product Code
- QRK
- UDI-DI
- 00853553005219
- PMA / PMN Number
- K133584
- Adverse Event
- 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 AN INFECTION AFTER PUNCTURING THEIR SKIN WITH THEIR LANCING DEVICE. THE PATIENT WENT TO THE EMERGENCY ROOM TO SEEK MEDICAL ATTENTION DUE TO A FEVER, BUT DIDN'T PROVIDE DETAILS OF THE MEDICAL TREATMENT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2466012 | LIVONGO LANCING DEVICE | LANCING DEVICE | QRK | TELADOC HEALTH INC. | N/A | 00853553005219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Unknown | Other |