BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16796264 · Received April 24, 2023

    Report

    Report Number
    3013756811-2023-57967
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    April 1, 2023
    Report Date
    April 24, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP. ADDITIONALLY, IT WAS REPORTED THAT THE CARTRIDGE O-RING WAS MISSING AND THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL PROCESS. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 201-225 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547118 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF