BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13549884 · Received February 17, 2022

    Report

    Report Number
    3013756811-2022-15874
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 17, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007295
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 PUMP BATTERY WAS DEPLETING QUICKLY. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO COMPLETE TROUBLESHOOTING; HOWEVER, NO RESPONSE WAS RECEIVED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 163-400 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863332 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male INFUSION SET: AUTOSOFT 90INSULIN: HUMALOG