BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELADOC BLOOD GLUCOSE METER

    MDR report key: 23767212 · Received December 10, 2025

    Report

    Report Number
    3011196194-2025-00108
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 13, 2025
    Report Date
    January 26, 2026
    Manufacturer
    TELADOC HEALTH, INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE RELATED TO THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INTERNAL FUNCTIONAL TESTING WAS PERFORMED, AND NO FAILURES WERE DETECTED DURING FUNCTIONAL TESTING. THE INTERNAL INVESTIGATION CONFIRMED THE DEVICE WAS WORKING AS INTENDED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED RECEIVING READINGS IN THE 20'S DUE TO THE READING, THE MEMBER DRANK JUICE AND VISITED THEIR PRIMARY CARE DOCTOR. AT THE DOCTORS OFFICE, A CAPILLARY LAB COMPARISON WAS DONE. THE TELADOC METER WAS 155 WHILE THE LAB RESULT WAS 245. THE READINGS WERE COMPLETED BACK-TO-BACK. THE MEMBER'S MEDICATION WAS ADJUSTED ALTHOUGH IT WAS UNDETERMINED IF THE ADJUSTMENT WAS MADE BASED ON THE TELADOC RESULT. IT WAS FOUND THE MEMBER WAS USING EXPIRED TEST STRIPS THAT WERE OPENED LONGER THAN 6 MONTHS AS WELL AS HAD THEM STORED IN A BAG.

    Description of Event or Problem · 0

    THE PATIENT REPORTED RECEIVING READINGS IN THE 20'S DUE TO THE READING, THE MEMBER DRANK JUICE AND VISITED THEIR PRIMARY CARE DOCTOR. ATH THE DOCTORS OFFICE, A CAPILLARY LAB COMPARISON WAS DONE. THE TELADOC METER WAS 155 WHILE THE LAB RESULT WAS 245. THE READINGS WERE COMPLETED BACK-TO-BACK. THE MEMBER'S MEDICATION WAS ADJUSTED ALTHOUGH IT WAS UNDETERMINED IF THE ADJUSTMENT WAS MADE BASED ON THE TELADOC RESULT. IT WAS FOUND THE MEMBER WAS USING EXPIRED TEST STRIPS THAT WERE OPENED LONGER THAN 6 MONTHS AS WELL AS HAD THEM STORED IN A BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871257 TELADOC BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH, INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Other