BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11607681 · Received April 2, 2021

    Report

    Report Number
    3013756811-2021-37737
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 2, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE WAS 210-211 MG/DL. REPORTEDLY, THE SAME CARTRIDGE WAS LOADED AND INSULIN DELIVERY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506401 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1