BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14120415 · Received April 15, 2022

    Report

    Report Number
    3013756811-2022-40362
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 21, 2022
    Report Date
    March 25, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007295
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF BETWEEN 241-500 MG/DL. REPORTEDLY, THE PUMP BATTERY COULD NOT BE CHARGED. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED. BG WAS TREATED WITH INTRAVENOUS INSULIN AND SALINE. REPORTEDLY, THE CUSTOMER WAS RELEASED ON (B)(6) 2022 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. REPORTEDLY, THE CUSTOMER WAS ABLE TO CHARGE THE PUMP WITH AN ALTERNATE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140697 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Hospitalization| R INSULIN: HUMALOG