BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 16113439 · Received January 6, 2023

    Report

    Report Number
    3013756811-2023-04212
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 6, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613700
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BASAL DELIVERIES. A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER TO RESOLVE THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 230 - 280 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514063 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 60372001 00850006613700

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female