BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9575030 · Received January 10, 2020

    Report

    Report Number
    3013756811-2020-05444
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    October 23, 2019
    Report Date
    January 10, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 A CARTRIDGE CHANGE ERROR OCCURRED DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND A MINIMUM FILL NOTIFICATION WAS RECEIVED. CUSTOMERS PUMP BATTERY WAS ALSO REPORTED TO BE DEPLETING QUICKLY WHICH LED TO AN UNEXPECTED SHUTDOWN. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 100-410 MG/DL. REPORTEDLY, THE CUSTOMER CHANGED PUMP SUPPLIES AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38772 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR