BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6095967 · Received November 11, 2016

    Report

    Report Number
    3007981285-2016-18655
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 22, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 RANGE (ABOVE 250- 370 MG/DL) THE CUSTOMER TOOK MANUAL INJECTIONS TO STABILIZE BG LEVELS. DURING THE CALL WITH TANDEM TECHNICAL SUPPORT (CTS), A SYSTEM CHECK WAS PERFORMED AND INDICATED THAT THE PUMP WAS FUNCTIONING AS INTENDED. REPORTEDLY, THE CUSTOMER HAS BEEN SICK FOR THE PAST 2 WEEKS AND IS ON MEDICATION. 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
    746570 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M018347

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other INFUSION SET: T90, INSULIN: NOVOLOG