BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO LANCET

    MDR report key: 16365009 · Received February 13, 2023

    Report

    Report Number
    3011196194-2023-00010
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 24, 2023
    Report Date
    February 7, 2023
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF THE SUPPLIES ARE RETURNED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT IS BEING FILED DUE TO THE PATIENT REPORTING FRAGMENTS OF THE LANCET BREAKING OFF INTO THEIR PUNCTURE WOUND WHEN ATTEMPTING TO USE THE LANCING DEVICE TO PUNCTURE THEIR SKING FOR A BLOOD GLUCOSE READING.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT WHEN THEY PUNCTURE THEIR SKIN WITH THE LIVONGO LANCING DEVICE THE LIVONGO LANCET BREAKS INTO SMALL PIECES. THE MEMBER STATED THAT THERE WOULD BE TINY SLIVERS OF THE LANCET LEFT IN THE PUNCUTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682308 LIVONGO LANCET LANCET QRK LIVONGO HEALTH INC 210184

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown