FDA Adverse Event
Malfunction
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 20354150
·
Received October 2, 2024
Report
- Report Number
- 3011196194-2024-00051
- Event Type
- Malfunction
- Date Received
- October 2, 2024
- Date of Event
- September 16, 2024
- Report Date
- September 30, 2024
- Manufacturer
- TELADOC HEALTH, INC.
- Product Code
- NBW
- PMA / PMN Number
- K133584
- 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. SHOULD THIS DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED TO DOCUMENT THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 0
THE PATIENT COMPLETED THE CONTROL SOLUTION 1 TEST, TWICE, WITH THEIR BLOOD GLUCOSE METER AND THE RESULTS WERE OUT OF RANGE. THE RANGE WAS 102-154 AND THE RESULT WAS 100 FOR BOTH TESTS. THE MEMBER DIDN'T RECEIVE ANY MEDICAL TREATMENT BECAUSE OF THE OUT OF RANGE RESULTS FROM THE TELADOC BLOOD GLUCOSE METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16834 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH, INC. | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Unknown |