BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13524653 · Received February 14, 2022

    Report

    Report Number
    3013756811-2022-11668
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    January 13, 2022
    Report Date
    February 14, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613700
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. REPORTEDLY, THE ALERT CLEARED, AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 325-1100 MG/DL. CUSTOMER ATTEMPTED TO ADDRESS ELEVATED BG WITH A BOLUS. ULTIMATELY, CUSTOMER WENT TO THE ER AND WAS ADMITTED TO THE HOSPITAL INTENSIVE CARE UNIT FOR THE ELEVATED BG. CUSTOMER WAS TREATED INTRAVENOUSLY WITH SALINE AND INSULIN. CUSTOMER WAS RELEASED ON (B)(6) 2022 WITH THE ISSUE RESOLVED. SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118723 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 49 YR Male Hospitalization| R