FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD GLUOCSE METER
MDR report key: 16533863
·
Received March 13, 2023
Report
- Report Number
- 3011196194-2023-00019
- Event Type
- Injury
- Date Received
- March 13, 2023
- Date of Event
- September 6, 2022
- Report Date
- March 10, 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
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 WERE RECEIVING READINGS BELOW 100 WITH THEIR LIVONGO BLOOD GLUCOSE METER, AND THAT READINGS ARE NOT CONSISTENT WITH READINGS RECEIVED AT THEIR DOCTOR'S OFFICE. THE PATIENT ALSO REPORTS THAT BECAUSE OF THE LOW READINGS, THEY CHANGED THEIR MEDICATION DOSES, CAUSING HIGHER BLOOD SUGAR AND A REPEAT ANGINA, WHICH RESULTED IN HAVING TO UNDERGO AN ANGIOPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 976645 | LIVONGO BLOOD GLUOCSE METER | BLODO GLUCOSE METER | NBW | LIVONGO HEALTH INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Unknown | Required Intervention| O |