FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 13122222
·
Received December 30, 2021
Report
- Report Number
- 3011196194-2021-00023
- Event Type
- Injury
- Date Received
- December 30, 2021
- Date of Event
- December 2, 2021
- Report Date
- December 27, 2021
- Manufacturer
- LIVONGO HEALTH INC
- Product Code
- NBW
- PMA / PMN Number
- K133584
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT REPORTED BEING ADMITTED TO THE HOSPITAL DUE TO LIVONGO'S METER READINGS WERE INACCURATE. MULTIPLE ATTEMPTS TO REACH THE MEMBER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. THE BG METER HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 0
THE MEMBER WAS HOSPITALIZED DUE TO A READING FROM THE LIVONGO'S METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2021471 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | LIVONGO HEALTH INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Hospitalization |