BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15784536 · Received November 11, 2022

    Report

    Report Number
    3013756811-2022-123368
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 11, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INSULIN GAUGE WAS INACCURATE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 153-158 MG/DL. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO COMPLETE TROUBLESHOOTING; HOWEVER, THE CUSTOMER DID NOT RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757580 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female