BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13018858 · Received December 16, 2021

    Report

    Report Number
    3013756811-2021-137681
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    December 6, 2021
    Report Date
    December 16, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP GREATER THAN 15 MINUTES, WITH NO CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READINGS. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 162-181 MG/DL. REPORTEDLY, THE TRANSMITTER AND THE PUMP REGAINED CONNECTION AND THE CUSTOMER CONTINUED TO USE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914929 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female INFUSION SET: TRUSTEEL, INSULIN: HUMALOG