BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16701275 · Received April 7, 2023

    Report

    Report Number
    3013756811-2023-49753
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 7, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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 THE PUMP DELIVERED MULTIPLE BOLUSES WITHOUT USER INPUT. THE CUSTOMER WAS PROVIDED CARBOHYDRATES BY AN ADULT ASSISTANT TO PREVENT BLOOD GLUCOSE LEVELS FROM DROPPING. REPORTEDLY, THE PUMP HISTORY INDICATES THAT THESE BOLUSES WERE PROGRAMMED MANUALLY, HOWEVER, THE CUSTOMER'S PARENTS DID NOT ACKNOWLEDGE THIS INFORMATION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 133-177 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794990 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown