BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9710903 · Received February 14, 2020

    Report

    Report Number
    3013756811-2020-14487
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 25, 2020
    Report Date
    February 14, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004781
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:SLIM X2 G5 USER GUIDE: "TAP CLOSE. CHANGE THE CARTRIDGE, TUBING, AND INFUSION SITE TO ENSURE PROPER DELIVERY OF INSULIN. RESUME INSULIN AFTER CHANGING THE CARTRIDGE, TUBING, AND INFUSION SITE." 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 CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. SUBSEQUENTLY, AN UNEXPECTED SHUT DOWN OCCURRED. REPORTEDLY, THE ALERT CLEARED AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE ALARM WAS CLEARED AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 220-243 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173728 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR