BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17558396 · Received August 16, 2023

    Report

    Report Number
    3013756811-2023-116623
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 16, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. PER THE TANDEM USER GUIDE: DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DELIVER AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER'S BG VALUE DISPLAYED AS 'LOW' ON THE CONTINUOUS GLUCOSE MONITOR (CGM). THE CAUSE OF LOW BG WAS UNKNOWN. THE CUSTOMER WAS ASLEEP AT THE TIME OF THE EVENT AND DID NOT ADDRESS THE LOW BG. TANDEM¿S CUSTOMER SUCCESS ADVOCATES (CSA) REVIEWED THE CUSTOMER¿S T:CONNECT DATA, AND IT WAS DISCOVERED THAT THE CUSTOMER ENTERED 192-221 GRAMS OF CARBOHYDRATES MANUALLY. RECOMMENDATION WAS MADE TO CONTACT TANDEM TECHNICAL SUPPORT (CTS) IF THE CUSTOMER EXPERIENCES ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893799 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male