BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 15198989 · Received August 10, 2022

    Report

    Report Number
    3013756811-2022-83671
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 19, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613700
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 130-225 MG/DL. REPORTEDLY, THE CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426195 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 27 YR Male INFUSION SET: AUTOSOFT XC INSULIN: NOVOLOG