BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM INSULIN PUMP WITH CONTROL IQ

    MDR report key: 10183832 · Received June 22, 2020

    Report

    Report Number
    MW5095148
    Event Type
    Injury
    Date Received
    June 22, 2020
    Date of Event
    June 19, 2020
    Report Date
    June 19, 2020
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TANDEM WITH CONTROL IQ DOES NOT GIVE CORRECTION INSULIN WHEN IN SLEEP MODE. TARGET RANGE IS ADVERTISED AS 110 TO 120 MG/DL FOR BLOOD GLUCOSE RANGE. CORRECTION IS SUPPOSED TO BE GIVEN VIA INCREASED TEMP BASAL INSULIN IF IN SLEEP MODE. YOU CAN SEE CONTROL IQ IS NOT DELIVERING INSULIN WITH THE CONTROL IQ FEATURE ENABLED. THIS FEATURE IS SUPPOSED TO GIVE INSULIN ACCORDING TO ONE'S CORRECTION FACTOR AND OTHER FACTORS INCLUDING, INSULIN ON BOARD ETC. THE CORRECTION FACTOR IS 11 WITH A BLOOD SUGAR LEVEL OF 152MG/DL. EIGHT INCREASED TEMP BASAL SHOULD HAVE BEEN APPLIED AUTOMATICALLY CONSIDERING THE CORRECTION FACTOR IS EIGHT, INCREASED TEMP BASAL SHOULD HAVE BEEN APPLIED AUTOMATICALLY CONSIDERING THE CORRECTION FACTOR IS 11 MG/DL WITH 0 INSULIN ON BOARD. CONTROL IQ FEATURE IS NOT WORKING CORRECTLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641766 TANDEM INSULIN PUMP WITH CONTROL IQ PUMP, INFUSION, INSULIN LZG TANDEM DIABETES CARE, INC. CONTROL IQ

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR