FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 16616179
·
Received March 24, 2023
Report
- Report Number
- 3011196194-2023-00027
- Event Type
- Injury
- Date Received
- March 24, 2023
- Date of Event
- March 6, 2023
- Report Date
- March 24, 2023
- Manufacturer
- LIVONGO HEALTH INC
- Product Code
- NBW
- PMA / PMN Number
- K133584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE METER ASSOCIATED WITH THIS REPORT WAS DISPOSED OF AND WAS NOT RETURNED FOR TESTING.
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THEIR LIVONGO BLOOD GLUCOSE METER WAS GIVING THEM FALSE LOW READINGS. THE PATIENT WENT TO THE HOSPITAL DUE TO THE LOW READINGS THEY WERE RECEIVING, ONCE THEIR BLOOD GLUCOSE WAS TESTED AT THE HOSPITAL IT WAS FOUND THAT THEIR BLOOD GLUCOSE LEVELS WERE MUCH HIGHER THAN THE READINGS PROVIDED BY THE LIVONGO BLOOD GLUOCSE METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367493 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | LIVONGO HEALTH INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Unknown | Hospitalization |