BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15642473 · Received October 20, 2022

    Report

    Report Number
    3013756811-2022-114684
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 20, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 200 UNITS OF INSULIN DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE ALARM 9 OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING COLD INSULIN AT THE TIME OF THE EVENT. TANDEM TECHNICAL SUPPORT (CTS) EDUCATED THE CUSTOMER THAT COLD INSULIN IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 223-232 MG/DL. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER REGARDING THE REPORTED ISSUE; HOWEVER, NO RESPONSE FROM THE CUSTOMER WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059912 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 W0518466 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female