BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 15584390 · Received October 11, 2022

    Report

    Report Number
    3013756811-2022-111851
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 20, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND STATIC. IN ADDITION, A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 250 UNITS OF INSULIN DURING THE LOAD SEQUENCE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUES. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140-260 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2896083 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 60352587 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male