BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12168014 · Received July 14, 2021

    Report

    Report Number
    3013756811-2021-73300
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 14, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP'S CONTROL IQ SOFTWARE WAS NOT FUNCTIONING AS INTENDED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200-260 MG/DL. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT FOR CUSTOMER TO UPLOAD PUMP DATA FOR REVIEW; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064419 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR