BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12832354 · Received November 17, 2021

    Report

    Report Number
    3013756811-2021-125021
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 30, 2021
    Report Date
    November 17, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 OCCLUSION ALARMS OCCURRED. A SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND THE OCCLUSION WAS FOUND TO BE WITHIN THE CARTRIDGE. CUSTOMER RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 110-146 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724620 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female INSULIN: NOVOLOG, INFUSION SET: AUTOSOFT XC