BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13224800 · Received January 11, 2022

    Report

    Report Number
    3013756811-2022-04470
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 11, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER SIMPLY CLEARED THE ALARM TO RESOLVE THE ISSUE AND RESUME INSULIN DELIVERY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS DELAYED IN RESPONDING TO PRESSES. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN DELIVERY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 151-173 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225090 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male INSULIN: NOVOLOGINFUSION SET: AUTOSOFT 90