BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12929020 · Received December 3, 2021

    Report

    Report Number
    3013756811-2021-133003
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 20, 2021
    Report Date
    December 3, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613700
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 RESISTANCE WAS FELT WHEN FILLING MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER CHANGED MULTIPLE CARTRIDGES AND MULTIPLE SYRINGE NEEDLES TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE WAS 140-175 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820491 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00850006613700

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female