BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7902034 · Received September 24, 2018

    Report

    Report Number
    3013756811-2018-33392
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 24, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    0085216200454590453581
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED CONTINUOUS ELEVATED BLOOD GLUCOSE (BG 250-455 MG/DL). THE PUMP SUPPLIES WERE CHANGED AND DIFFERENT INFUSION INSERTION SITES WERE USED. BG DID NOT LOWER. KETONES WERE PRESENT. CUSTOMER WENT TO THE EMERGENCY ROOM (ER) AND WAS TREATED WITH INSULIN. AFTER 3 HOURS CUSTOMER LEFT THE ER IN GOOD CONDITION AND BG WAS BELOW 200 MG/DL. CONTACT ALLEGED THE PUMP WAS NOT DELIVERING INSULIN PROPERLY AND REVERTED TO USING MANUAL INJECTIONS FOR INSULIN THERAPY. AS THE CUSTOMER WAS NOT USING THE PUMP, THE CONTACT DECLINED TANDEM TECHNICAL SUPPORT'S OFFER TO PERFORM A SYSTEM CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743067 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 0085216200454590453581

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention