BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 8401603 · Received March 7, 2019

    Report

    Report Number
    3011196194-2019-00002
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    December 1, 2018
    Report Date
    January 23, 2019
    Manufacturer
    LIVONGO HEALTH INC.
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE BLOOD GLUCOSE METER NOR THE TEST STRIPS WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MEMBER'S WIFE WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE TEST STRIPS IN USE. IT IS UNKNOWN IF THE TEST STRIPS BEING USED BY THE MEMBER WERE OPENED GREATER THAN 6 MONTH BEFORE USING AND WERE THEREFORE, EXPIRED. AN INVESTIGATION WILL BE CONDUCTED BUT HAS NOT YET BEEN STARTED. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE MEMBER'S WIFE REPORTED THAT THE LIVONGO BG300 METER GENERATED ERRONEOUSLY LOW BLOOD GLUCOSE RESULTS. THE MEMBER HAD A REGULARLY SCHEDULED DOCTOR'S APPOINTMENT APPROXIMATELY ONE MONTH AGO. THE MEMBER'S WIFE DID NOT REMEMBER THE EXACT DATE SO THE DATE OF (B)(6) 2018 IS BEING USED AS THE DATE OF THE EVENT. THE MEMBER HAD NOT BEEN FEELING WELL AND HAD CONCERNS THAT THE LIVONGO BLOOD GLUCOSE METER WAS PROVIDING ERRONEOUSLY LOW READINGS. THE MEMBER'S DOCTOR OBTAINED A HIGH RESULT ON AN UNKNOWN METER AND HOSPITALIZED THE MEMBER BASED ON THIS HIGH RESULT. THE HIGH RESULT WAS NOT PROVIDED. THE MEMBER WAS TREATED BUT THE MEMBER'S WIFE COULD NOT REMEMBER THE METHOD OF TREATMENT THE MEMBER RECEIVED. THE MEMBER'S WIFE STATED THE DOCTOR ALSO TESTED THE MEMBER USING THE LIVONGO METER AND OBTAINED A LOW RESULT. THE LOW RESULT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194564 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC. BG300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R