BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 10523564 · Received September 11, 2020

    Report

    Report Number
    3011196194-2020-00034
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 11, 2020
    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 · 1

    THE BG METER HAVE NOT BEEN RETURNED TO 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 HAD REPORTED THAT THEY HAD IMMEDIATELY GONE TO A MEDICAL CLINIC AFTER A READING OF 92 ON HIS LIVONGO MONITOR, AND EXPERIENCED MULTIPLE SYMPTOMS OF LOW BLOOD SUGAR. HIS OTHER DEVICE, A FREESTYLE LITE WAS RUNNING IN THE LOW 50S AT THE TIME AND THE PATIENT SOUGHT IMMEDIATE TREATMENT WHICH INCLUDED BEING PROVIDED GLUCOSE. THE PATIENT WAS SENT A REPLACEMENT BLOOD GLUCOSE METER AND TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988146 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention