BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10361653 · Received August 4, 2020

    Report

    Report Number
    3013756811-2020-80622
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 4, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE CUSTOMER EXPERIENCED ONGOING BLOOD GLUCOSE (BG) LEVEL RANGING FROM 350-525 MG/DL AND DIABETIC KETOACIDOSIS. REPORTEDLY, CUSTOMER BELIEVED THAT THE INFUSION SET WAS NOT FUNCTIONING PROPERLY; HOWEVER, NO INFUSION SET DAMAGE WAS NOTED AND THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION ABOUT THE SUSPECTED CAUSE. BG WAS ADDRESSED VIA A MANUAL INJECTION. THE CUSTOMER WAS INSTRUCTED TO CONSULT WITH HEALTHCARE PROVIDER REGARDING BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826366 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 64 YR Other