BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12829998 · Received November 17, 2021

    Report

    Report Number
    3013756811-2021-126087
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 17, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007318
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PUMP SHUTDOWN DUE TO NORMAL DEPLETION. AFTER TURNING THE PUMP BACK ON, THE PUMP INDICATED A DATA LOG CORRUPTION AND THE CUSTOMER¿S PERSONAL PROFILE SETTINGS WERE NOTED TO BE MISSING. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 160-240 MG/DL. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725400 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male