FDA Adverse Event
Injury
Summary report: N
TELADOC BLOOD GLUCOSE METER
MDR report key: 23924086
·
Received December 30, 2025
Report
- Report Number
- 3011196194-2025-00112
- Event Type
- Injury
- Date Received
- December 30, 2025
- Date of Event
- December 1, 2025
- Report Date
- December 30, 2025
- Manufacturer
- TELADOC HEALTH INC
- Product Code
- NBW
- PMA / PMN Number
- K133584
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DUE TO THE PATIENTS ACCOUNT BEING INACTIVE, WE CANNOT PROVIDE NEW SUPPLIES OR A REPLACEMENT METER. THE PATIENT WAS INFORMED NOT TO USE EXPIRED SUPPLIES AND ADVISED TO CONTACT THEIR BENEFIT PROVIDER FOR FURTHER OPTIONS.
Description of Event or Problem · 0
THE PATIENT REPORTED RECEIVING LOW INACCURATE BLOOD GLUCOSE READINGS THAT DIDN'T ALIGN WITH THEIR SYMPTOMS. FIVE MINUTES BEFORE CALLING AN AMBULANCE THE MEMBER CHECKED THEIR BLOOD GLUCOSE WHICH SHOWED 160. THEY WERE THEN TAKEN TO THE ER, WHERE THEY RECEIVED IV FLUIDS AND HAD THEIR BLOOD GLUCOSE THEN READING 263. MEMBER SUPPORT CONFIRMED THE MEMBER WAS USING EXPIRED SUPPLIES WHEN TESTING THEIR BLOOD GLUCOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1887517 | TELADOC BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown | Other |