BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12253977 · Received July 30, 2021

    Report

    Report Number
    3013756811-2021-82702
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 30, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 150 UNITS OF INSULIN DURING THE LOAD SEQUENCE. IN ADDITION, CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. IT WAS ALSO REPORTED THAT THE CUSTOMER EXPERIENCED DIFFICULTY DURING THE LOAD FILL TUBING PROCESS. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BETWEEN 220-299 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152357 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 M859944 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INSULIN: NOVOLOG / NOVORAPID.| INSULIN: NOVOLOG / NOVORAPID.