BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 17510002 · Received August 11, 2023

    Report

    Report Number
    3013756811-2023-111587
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 14, 2023
    Report Date
    August 11, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE CARTRIDGES WERE LEAKING FROM THE CARTRIDGE TUBING. CUSTOMER LOADED A NEW CARTRIDGE TO ADDRESS THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 180-225 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869447 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 60412162 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female INFUSION SET: AUTOSOFT 90INSULIN: NOVOLOG / NOVOR