BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 16549932 · Received March 15, 2023

    Report

    Report Number
    3011196194-2022-00022
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    March 5, 2023
    Report Date
    March 15, 2023
    Manufacturer
    LIVONGO 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 METER ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RECEIVED FOR TESTING. IF RECEIVED, THE METER WILL BE TESTED AND A SUPPLEMENTAL REPORT FILED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR LIVONGO BLOOD GLUCOSE METER WAS GIVING THEM FALSE LOW READINGS. THE PATIENT PROCEEDED TO SELF TREAT TO BRING THEIR BLOOD GLUCOSE READINGS UP BY CONSUMING SUGAR AND CARBS. THE PATIENT CONTINUED TO RECEIVE LOW READINGS AND SOUGHT MEDICAL ATTENTION AS HIS BLOOD SUGAR WAS NOT RAISING AS EXPECTED. THE PATIENT RECEIVED A BLOOD GLUCOSE READING OF 256 FROM THE HOSPITAL AND 125 FROM THE LIVONGO BLOOD GLUCOSE METER. THE HOSPITAL GAVE THE PATIENT SALINE SOLUTION AFTER HE EXPLAINED WHAT HAPPENED, AND WAS RELEASED AFTER HIS BLOOD GLUCOSE READING CAME DOWN TO 160.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757940 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH, INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization