BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11922564 · Received June 2, 2021

    Report

    Report Number
    3013756811-2021-55618
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 9, 2021
    Report Date
    June 2, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007257
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 140-155 MG/DL. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER DID NOT RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819579 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR