BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T SLIM X2

    MDR report key: 12665160 · Received October 19, 2021

    Report

    Report Number
    MW5104776
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    October 16, 2021
    Report Date
    October 16, 2021
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DEXCOM G6 IS WILDLY INACCURATE WHEN CONNECTED TO MY TANDEM T SLIM X2 PUMP. THE ALGORITHM CLEARLY CHANGES WHEN CONTROL IQ, WHICH RUNS THE INSULIN DELIVERY, IS TURNED ON. WHEN THAT PROGRAM IS TURNED OFF, THE G6 IS QUITE ACCURATE. THE ISSUE IS THAT TANDEM WILL NOT ADMIT THAT THEY HAVE CHANGED THE ALGORITHM OF THE G6 TO WORK THE CIQ SYSTEM, MEANING THAT CONSUMERS ARE UNAWARE THAT IT CHANGES THE DATA, AND THIS ISSUE COULD LEAD TO SERIOUS ADVERSE EVENTS FOR DIABETICS LIKE ME. TODAY, THE CIQ ALGORITHM MADE THE G6 AT LEAST 30 POINTS TOO LOW, CUTTING OFF INSULIN WHEN I NEEDED IT AND CAUSING A 30 POINT BLOOD GLUCOSE RISE IN 20 MINUTES. WHEN I TURNED OFF CIQ, THE DEXCOM CORRECTED ITSELF AND WAS ACCURATE. CONSUMERS SHOULD BE ADVISED OF THIS CHANGE IN THE WAY THE SENSOR WORKS ON THEIR PROGRAM AND SHOULD BE WARNED TO KEEP AN EYE ON BLOOD GLUCOSE LEVELS WHEN BY DOING A METER WHEN USING DEXCOM AND CIQ. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559978 TANDEM T SLIM X2 PUMP, INFUSION, INSULIN LZG TANDEM DIABETES CARE, INC. 7600001

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR