BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6112808 · Received November 18, 2016

    Report

    Report Number
    3007981285-2016-20313
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 30, 2016
    Report Date
    October 30, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HAD EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL RANGE (275-460 MG/DL) THE CUSTOMER CHANGED THE INFUSION SET SITE AND DELIVERED A BOLUS TO STABILIZE BG LEVEL. REPORTEDLY, THE CUSTOMER HAD FLU LIKE SYMPTOMS AND WAS VOMITING. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT (CTS), A SYSTEM CHECK WAS PERFORMED AND INDICATED THAT THE PUMP WAS FUNCTIONING AS INTENDED. 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
    763077 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other INFUSION SET: T90, INSULIN: HUMALOG