BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 10254719 · Received July 9, 2020

    Report

    Report Number
    3011196194-2020-00028
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 29, 2020
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE BLOOD GLUCOSE METER NOR THE TEST STRIPS HAVE BEEN RETURNED TO THE MANUFACTURER. THE DEVICE HAS YET TO BE RECEIVED BY THE MANUFACTURER, SHOULD THE DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE TESTING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A COMPLAINT THAT THEIR METER WAS NOT ACCURATE. THE METER WAS COMPARED TO A LAB SAMPLE, AND THE PATIENT REPORTED THE DIFFERENCE BETWEEN THE LIVONGO METER AND THE CAPILLARY TEST WAS GREATER THAN 20%, ALTHOUGH THE EXACT METHOD OF THE CAPILLARY TEST IS UNKNOWN. THE PATIENT WAS SENT A REPLACEMENT BLOOD GLUCOSE METER AND TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715436 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR