BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9590985 · Received January 15, 2020

    Report

    Report Number
    3013756811-2020-06858
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 31, 2019
    Report Date
    January 15, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007301
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING THE CARTRIDGE WITH 150 UNITS OF INSULIN. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE CHANGE ERROR OCCURRED DURING THE LOAD SEQUENCE AND EXPERIENCED A LEAKING CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 100-234 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54968 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR INSULIN: NOVOLOG/NOVORAPID