BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14791964 · Received June 23, 2022

    Report

    Report Number
    3013756811-2022-69487
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 10, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER TANDEM'S USER GUIDE: IF YOU DROP YOUR PUMP OR IT HAS BEEN HIT AGAINST SOMETHING HARD, ENSURE THAT IT IS STILL WORKING PROPERLY. ADDITIONALLY, YOUR PUMP IS WATERTIGHT TO A DEPTH OF 3 FEET (0.91 METERS) FOR UP TO 30 MINUTES (IPX7 RATING), BUT IT IS NOT WATERPROOF. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, BUT A TEMPERATURE ALARM OCCURRED. REPORTEDLY, THE PUMP HAD BEEN DROPPED IN A BATHTUB THE NIGHT PRIOR TO THE ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY WILL STOP CHARGING AFTER A COUPLE MINUTES. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 100-194 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241106 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male