BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12676141 · Received October 21, 2021

    Report

    Report Number
    3013756811-2021-110555
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 21, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN MULTIPLE INTERMITTENT INSTANCES WHERE INSULIN GAUGE WAS INACCURATE. IN ADDITION, A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 170-250 MG/DL. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY UNTIL REPLACEMENT ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571008 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60284615 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male