BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12183489 · Received July 16, 2021

    Report

    Report Number
    3013756811-2021-76464
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 16, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF APPROXIMATELY 50 MG/DL. REPORTEDLY, CUSTOMER DELIVERED TOO LARGE OF A BOLUS FOR THE AMOUNT OF CARBOHYDRATES CONSUMED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY FULLY DEPLETED AND THE PUMP SHUT OFF DUE TO THE CUSTOMER NOT CHARGING THE PUMP. SUBSEQUENTLY, THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE LEVEL OF 465 MG/DL, NAUSEA, AND DIABETIC KETOACIDOSIS. CUSTOMER REQUIRED ASSISTANCE TO TREAT BG LEVEL VIA MANUAL INJECTIONS. THE PUMP USER GUIDE STATES, "TANDEM DIABETES CARE, INC. RECOMMENDS PERIODICALLY CHECKING THE BATTERY LEVEL INDICATOR, CHARGING THE PUMP FOR A SHORT PERIOD OF TIME EVERY DAY (10 TO 15 MINUTES), AND ALSO AVOIDING FREQUENT FULL DISCHARGES."

    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 A LOW BLOOD GLUCOSE (BG) LEVEL (VALUE NOT PROVIDED). REPORTEDLY, THE CUSTOMER REQUIRED ASSISTANCE TO TREAT BG LEVEL. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076997 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention