FDA Adverse Event
Malfunction
Summary report: N
LIVONGO BLOOD GLUCOSE METER
MDR report key: 19660656
·
Received July 2, 2024
Report
- Report Number
- 3011196194-2024-00032
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Date of Event
- April 23, 2024
- Report Date
- July 2, 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 NEW SUPPLIES TO PERFORM CONTROL SOLUTION TESTS AGAIN. MULTIPLE ATTEMPTS WERE MADE TO REACH THE PATIENT AND WERE UNSUCCESSFUL. WE WERE UNABLE TO RUN CONTROL SOLUTION TESTS AGAIN WITH THE PATIENT, AND THE DEVICE WAS NOT RETURNED FOR THE INVESTIGATION.
Description of Event or Problem · 0
THE PATIENT PERFORMED CONTROL SOLUTION TESTS WITH THE LIVONGO BLOOD GLUCOSE METER AND THE RESULTS CAME BACK OUT OF RANGE TWICE. THE RESULT FOR CONTROL SOLUTION 1 CAME BACK AS 158, AND 216. THE PRE-CALIBRATED RANGE FOR CONTROL 1 WAS 98-147. THE PATIENT DIDN'T RECEIVE MEDICAL ATTENTION AND/OR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755827 | LIVONGO BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH, INC. | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Unknown |