BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8499729 · Received April 10, 2019

    Report

    Report Number
    3013756811-2019-17599
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 9, 2019
    Report Date
    April 10, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE T:SLIM USER GUIDE: REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG®; EVERY 72 HOURS IF USING NOVOLOG®. THE CARTRIDGE INSTRUCTIONS FOR USE STATE: MAKE SURE THAT INSULIN IS ROOM TEMPERATURE BEFORE FILLING THE CARTRIDGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCE CONTINUOUS ELEVATED BLOOD GLUCOSE (BG) RANGING FROM 192-519 MG/DL. INFUSION SET WAS CHANGED MULTIPLE TIMES AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS BG. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (CTS) AND PUMP WSA FOUND TO BE FUNCTIONING AS INTENDED. REPORTEDLY, CUSTOMER CHANGED OUT THE CARTRIDGE EVERY 3 DAYS AND COLD INSULIN WAS USED TO FILL THE CARTRIDGE. CTS INFORMED THE CONTACT THAT HUMALOG INSULIN WAS LABELED FOR 48 HOUR USE WITH THE PUMP AND INSULIN WAS TO BE ROOM TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293371 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG