BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8165834 · Received December 14, 2018

    Report

    Report Number
    3013756811-2018-45623
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 14, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY WAS UNABLE TO CHARGE DESPITE USING MULTIPLE USB CABLES, WALL ADAPTERS AND POWER SOURCES. THE CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 110-218 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004177 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR