BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6078759 · Received November 4, 2016

    Report

    Report Number
    3007981285-2016-19452
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    August 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGE (ABOVE 250-350 MG/DL) THE CUSTOMER WOULD DELIVER BOLUSES TO ADDRESS BG LEVELS. THE CUSTOMER DECLINED TO TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT. IT WAS INDICATED THAT THE CUSTOMER WOULD DISCUSS WITH THE HEALTH CARE PROVIDER FACTORS THAT MAY AFFECT BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731661 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other