BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16673240 · Received April 4, 2023

    Report

    Report Number
    3013756811-2023-44766
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 10, 2023
    Report Date
    April 10, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 0

    H10 REMOVED; REMOVE MDR CODE: 11, 3233, 4118; ADD MDR CODE: 10, 120, 23.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 200-250 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130253 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 32 YR Male