BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11177437 · Received January 15, 2021

    Report

    Report Number
    3013756811-2021-02670
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 24, 2020
    Report Date
    January 15, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613229
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 160-335 MG/DL. CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA PUMP TO ADDRESS BG. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. TROUBLESHOOTING WAS PERFORMED AND THE OCCLUSION WAS FOUND TO BE WITHIN THE CARTRIDGE. A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE OCCLUSION ALARM. NO ADDITIONAL PATIENT OR EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77815 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613229

    Patients

    Seq Age Sex Outcome Treatment
    1