BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6270091 · Received January 23, 2017

    Report

    Report Number
    3007981285-2017-00389
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    December 25, 2016
    Report Date
    January 23, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 SINCE (B)(6) 2016 (200-320 MG/DL). CUSTOMER STATED THE SUSPECTED CAUSE OF HIGH BG WAS HOLIDAY ACTIVITIES, HABITS, AND FOOD. BOLUSES WERE USED TO ADDRESS ELEVATED BG LEVEL. THE CUSTOMER DECLINED TO PERFORM TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AT THE TIME OF THE CALL AND STATED THEY HAVE AN APPOINTMENT SCHEDULED WITH THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52607 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other