BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14253044 · Received April 29, 2022

    Report

    Report Number
    3013756811-2022-42740
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 10, 2022
    Report Date
    April 10, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. SUBSEQUENTLY, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHEN FILLING THE CARTRIDGE WITH INSULIN AND THAT THE CARTRIDGE WAS LEAKING FROM THE O-RING. THE ISSUE WAS RESOLVED BY PERFORMING A SUPPLY CHANGE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130-153 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118234 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0229154 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female INFUSION SET: AUTOSOFT 90INSULIN: HUMALOG