BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11784461 · Received May 6, 2021

    Report

    Report Number
    3013756811-2021-47329
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 6, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET TO ADDRESS THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 143-150 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679909 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 21 YR