BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 19712452 · Received July 10, 2024

    Report

    Report Number
    3011196194-2024-00028
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 10, 2024
    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 PATIENT WAS SENT A NEW DEVICE AND SUPPLIES. THE DEVICE HAS NOT YET BEEN RETURNED FOR THE INVESTIGATION. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A SUPPLEMENTARY REPORT WILL BE FILED

    Description of Event or Problem · 0

    THE PATIENT PERFORMED CONTROL SOLUTION TESTS WITH THE LIVONGO BLOOD GLUCOSE METER AND THE RESULTS CAME BACK OUT OF RANGE TWICE. THE RESULT FOR CONTROL SOLUTION 1 CAME BACK AS 95, AND 88. THE PRE-CALIBRATED RANGE FOR CONTROL 1 WAS 103-155. THE PATIENT DIDN'T RECEIVE MEDICAL ATTENTION AND/OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040651 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH, INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown