BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6049022 · Received October 21, 2016

    Report

    Report Number
    3007981285-2016-15457
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 4, 2016
    Report Date
    October 2, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM CARTRIDGE USER GUIDE INDICATES THAT HUMALOG HAS BEEN TESTED UP TO 48 HOURS. REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGE FROM (230-286 MG/DL) FOR THE PAST MONTH. THE CUSTOMER WOULD BOLUS TO STABILIZE BG LEVEL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT (CTS), A SYSTEM CHECK WAS PERFORMED AND INDICATED THAT THE PUMP WAS FUNCTIONING AS INTENDED. THE CUSTOMER STATED TO USE HUMALOG INSULIN IN THE CARTRIDGE FOR 3-3.5 DAYS. THE CUSTOMER WAS EDUCATED PER HUMALOG LABELING IT IS ONLY TESTED FOR UP TO 48 HOURS. A RECOMMENDATION WAS MADE FOR THE CUSTOMER TO CONTACT THE HEALTHCARE PROVIDER TO DISCUSS FACTORS THAT MAY AFFECT BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700163 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other INFUSION SET: INSET, INSULIN: HUMALOG