BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 17392697 · Received July 25, 2023

    Report

    Report Number
    3011196194-2023-00066
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    May 20, 2023
    Report Date
    July 17, 2023
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED YET. SHOULD THE DEVICE BE RETURNED AT A LATER DATE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THE LIVONGO BLOOD GLUCOSE METER WAS PROVINDING READINGS THAT WERE 30 POINTS TOO HIGH. THE PATIENT REPORTED THAT THEY WERE OVER MEDICATING BASED ON THEIR LIVONGO READINGS. THE PATIENT ADMINISTERED 45 UNITS OF HUMULIN AFTER RECEIVING A READING OF 200 FROM THE LIVONGO BLOOD GLUCOSE METER. AFTERWARDS, HE BEGAN TO EXPERIENCE SYMPTOMS OF LOW BLOOD SUGAR AND HE ATE CANDY TO BRING HIS BLOOD SUGAR BACK UP. THE PATIENT ALSO OBTAINED A LAB COMPARISON TO A CAPILLARY LAB TEST RESULT. THE LAB TEST RESULT WAS 135 AND THE LIVONGO METER'S RESULT WAS 168, WHICH IS OUTSIDE OF THE +/- 20% RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554080 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH, INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other