FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 19838723
·
Received July 26, 2024
Report
- Report Number
- 3011196194-2024-00039
- Event Type
- Injury
- Date Received
- July 26, 2024
- Date of Event
- July 2, 2024
- Report Date
- July 26, 2024
- Manufacturer
- TELADOC HEALTH INC
- Product Code
- NBW
- 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 THAT THEY BLACKED OUT DUE TO THEIR METER DISPLAYING AN UNSPECIFIED ERROR MESSAGE WHEN ATTEMPTING TO TAKE A BLOOD GLUCOSE READING. THE PATIENT WENT TO THE HOSPITAL TO SEEK MEDICAL ATTENTION DUE TO HAVING LOW BLOOD SUGAR, BUT DID NOT PROVIDE DETAILS OF THE MEDICAL TREATMENT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614449 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Unknown | Other| H |