BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9586705 · Received January 14, 2020

    Report

    Report Number
    3013756811-2020-01800
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 29, 2019
    Report Date
    January 14, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S PUMP USER GUIDE, "DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS." 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 ACCIDENTALLY OVERRODE THE RECOMMENDED BOLUS AMOUNT CAUSING THE PUMP TO DELIVER A 8 UNIT BOLUS. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED BETWEEN 120-237 MG/DL. TANDEM TECHNICAL SUPPORT PROVIDED ADDITIONAL TRAINING IN REGARDS TO BOLUS DELIVERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50254 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 10 YR