BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9954825 · Received April 13, 2020

    Report

    Report Number
    3013756811-2020-36273
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    February 28, 2020
    Report Date
    April 13, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED BETWEEN 220-600 MG/DL WITH HIGH KETONES. CUSTOMER WAS TAKEN TO THE ER AND RECEIVED BAGS OF INSULIN AND ADMINISTERED A MANUAL INJECTION TO ADDRESS BG LEVELS. CUSTOMER'S BG LEVEL WAS 170 MG/DL AND WAS STABLE UPON LEAVING ER. REPORTEDLY, THE CUSTOMER CHANGED PUMP SUPPLIES TO RESOLVE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418325 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention INSULIN: HUMALOG