FDA Adverse Event
Injury
Summary report: N
TELADOC BLOOD GLUCOSE METER
MDR report key: 23679236
·
Received December 1, 2025
Report
- Report Number
- 3011196194-2025-00102
- Event Type
- Injury
- Date Received
- December 1, 2025
- Date of Event
- November 12, 2025
- Report Date
- November 19, 2025
- Manufacturer
- TELADOC HEALTH, INC
- Product Code
- NBW
- PMA / PMN Number
- K133584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MEMBER SUPPORT SENT A REPLACEMENT METER AND REQUESTED THE RETURN OF THEIR METER. THE METER HAS NOT BEEN RETURNED. 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 A COMPLAINT REGARDING INCONSISTENT BLOOD SUGAR READINGS FROM THE TELADOC BLOOD GLUCOSE METER, NOTING THAT RESULTS FROM DIFFERENT BATCHES OF TEST STRIPS VARIED BY 100 POINTS. THE PATIENT STATED THAT AFTER RECEIVING THE HIGH READINGS, THEY CONTACTED THEIR DOCTOR AND WERE ADVISED TO INCREASE THEIR METFORMIN DOSAGE FROM 750 MG TO 1000 MG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2092157 | TELADOC BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH, INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Unknown | Other |