BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11217516 · Received January 22, 2021

    Report

    Report Number
    3013756811-2021-03770
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 22, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS MISSING DATA POINTS ON THE CONTINUOUS GLUCOSE MONITOR GRAPH. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT WAS PERFORMED AND REPORTEDLY, THE CUSTOMER SUCCESSFULLY STARTED A SENSOR SESSION. ADDITIONALLY, IT WAS REPORTED THAT AN AUTO-OFF ALARM OCCURRED. CUSTOMER CONFIRMED THAT THERE HAD BEEN NO INTERACTION WITH THE PUMP FOR AN EXTENDED PERIOD. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON THE PUMP'S AUTO-OFF SAFETY FEATURE PER USER GUIDE AND ADVISED THE CUSTOMER TO CONSULT WITH HEALTHCARE PROVIDER PRIOR TO MODIFYING THE SETTING. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 152-205 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113771 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 74 YR