FDA Adverse Event
Injury
Summary report: N
TELADOC BLOOD GLUCOSE METER
MDR report key: 23655528
·
Received November 26, 2025
Report
- Report Number
- 3011196194-2025-00103
- Event Type
- Injury
- Date Received
- November 26, 2025
- Date of Event
- November 5, 2025
- Report Date
- November 21, 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
THE PATIENT WAS OFFERED NEW SUPPLIES AND THEY DECLINED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION WITH NO SUCCESS. THE PATIENT'S BLOOD GLUCOSE METER WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. 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 USED A TELADOC BLOOD GLUCOSE METER AND RECEIVED AN INACCURATE READING, WHICH CAUSED THEM TO GO TO AN URGENT CARE. THE PATIENT DID NOT PROVIDE ADDITIONAL INFORMATION ABOUT ANY MEDICAL TREATMENT OR INTERVENTION AS A RESULT OF THE READING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2812893 | TELADOC BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH, INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Unknown | Other |