BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13472519 · Received February 7, 2022

    Report

    Report Number
    3013756811-2022-11993
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 8, 2022
    Report Date
    January 15, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 49MG/DL. REPORTEDLY, THE CUSTOMER WAS EXPERIENCING AN INACCURATE CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READING, AND SUBSEQUENTLY INPUT THE INACCURATE BG VALUE INTO THE BOLUS MENU. AS CUSTOMER'S BG LEVEL WAS LOWER THAN THE CGM READING, THE BOLUS WAS TOO LARGE FOR THE CUSTOMER'S ACTUAL BG LEVEL. CGM READING VALUES WERE NOT PROVIDED. BG WAS ADDRESSED VIA CONSUMPTION OF CARBOHYDRATES. THE CUSTOMER WAS INSTRUCTED TO CONSULT WITH HEALTHCARE PROVIDER REGARDING BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497229 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other