FDA Adverse Event
Malfunction
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 19693842
·
Received July 8, 2024
Report
- Report Number
- 3011196194-2024-00027
- Event Type
- Malfunction
- Date Received
- July 8, 2024
- Date of Event
- June 10, 2024
- Report Date
- July 8, 2024
- Manufacturer
- TELADOC HEALTH, INC.
- Product Code
- NBW
- PMA / PMN Number
- K133584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT WAS SENT A REPLACEMENT DEVICE. THE DEVICE THAT IS BEING REPORTED ON WAS REQUESTED BACK FOR TESTING. THE DEVICE HAS NOT YET BEEN RETURNED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THEY TOOK THEIR METER TO THEIR DOCTOR'S OFFICE AND COMPARED THEIR METER AGAINST A CAPILLARY LAB TEST RESULT. THE LIVONGO METER GAVE A READING OF 130 WHILE THE LAB TEST GAVE A READING OF 106/107.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861968 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH, INC. | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown |