FDA Adverse Event
Injury
Summary report: N
TELADOC BLOOD GLUCOSE METER
MDR report key: 23732540
·
Received December 5, 2025
Report
- Report Number
- 3011196194-2025-00107
- Event Type
- Injury
- Date Received
- December 5, 2025
- Manufacturer
- TELADOC HEALTH, INC
- Product Code
- NBW
- PMA / PMN Number
- K133584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS NOT RETURNED FOR THE INVESTIGATION. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
THE PATIENT REPORTED RECEING LOW READINGS OF 54. AFTER CONSUMING PEANUT BUTTER AND ORANGE JUICE TWICE AND WAITED 30-40 MINUTES, THEY GOT A READING OF 54 AGAIN. BECAUSE OF THE LOW READINGS, THE PATIENT WENT TO SEE THEIR DOCTOR. READINGS AT THE DOCTOR'S OFFICE WAS 400 AND THE PATIENT RECEIVED A SHOT. THE PATIENT ALSO COMPARED READINGS WITH A FREESTYLE LIBRE AND A ONETOUCH DEVICES WHICH INDICATED READINGS OF 186 AND 134 RESPECTIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2108677 | TELADOC BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | TELADOC HEALTH, INC | BG300C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Unknown | Other |