BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11615778 · Received April 5, 2021

    Report

    Report Number
    3013756811-2021-36889
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 13, 2021
    Report Date
    April 5, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 100 UNITS OF INSULIN DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER DISCONNECTED INFUSION SET FROM THE CARTRIDGE, DELIVERED 5-6 UNITS, AND DID NOT OBSERVE ANY DROPS OF INSULIN EXITING FROM THE END OF THE CARTRIDGE TUBING. THE CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUES. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 213-228 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510098 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR