BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11014493 · Received December 15, 2020

    Report

    Report Number
    3013756811-2020-145953
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 15, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE: CHECK YOUR PUMP'S PERSONAL SETTINGS REGULARLY TO ENSURE THEY ARE CORRECT. INCORRECT SETTINGS CAN RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. 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 INCORRECTLY ENTERED PUMP CORRECTION FACTOR SETTING. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, SETTING WAS CORRECTED AND INSULIN THERAPY WAS SUCCESSFULLY RESUMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 163 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473552 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 51 YR