BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T SLIM INSULIN PUMP

    MDR report key: 15605937 · Received October 13, 2022

    Report

    Report Number
    MW5112624
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    October 10, 2022
    Report Date
    October 11, 2022
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM THE USER OF A T-SLIM INSULIN PUMP. I USE AUTOSOFT XC INFUSION SET. ON THE MORNING OF (B)(6) 2022, MY PUMP WAS READY FOR A RESERVOIR AND INFUSION SET CHANGE, SO I DID SO AROUND 1030 AM. I BOLUSED FOR LUNCH AS USUAL. ABOUT 2 O'CLOCK, I REALIZED THAT MY SENSOR GLUCOSE READING WAS HIGH (290) AND TRENDING HIGHER. I KNEW MY T-SLIM WOULD ADJUST, SO I CONTINUED ON WITH MY DAY. BY 4 PM, MY SENSOR GLUCOSE WAS OVER 400. I HAVE NOT BEEN THIS HIGH IN YEARS AND WAS SHOCKED. COULD NOT GET IT TO COME DOWN. DURING A TRIP TO THE BATHROOM, I DISCOVERED THE TUBING WAS NOT CONNECTED TO THE INFUSION SET. THE SET WAS PROPERLY APPLIED TO MY SKIN AND THE CANNULA WAS UNDER MY SKIN BUT THE TUBING WAS NOT CONNECTED TO THE SET (SO IMPOSSIBLE FOR INSULIN TO BE DELIVERED). LOT NUMBER OF THE AUTOSOFT XC IS 5353235; EXPIRATION DATE OF AUTOSOFT XC IS AUG 1, 2024. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241329 T SLIM INSULIN PUMP PUMP, INFUSION, INSULIN LZG TANDEM DIABETES CARE, INC.
    2241330 AUTOSOFT XC INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR LZG UNOMEDICAL A/S 5353235

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DEXCOM G6 SENSOR