BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5830371 · Received July 28, 2016

    Report

    Report Number
    3007981285-2016-94072
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE (BG) LEVELS (241-293 MG/DL). A CORRECTION BOLUS WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER THOUGHT THAT THE PUMP WAS NOT DELIVERING THE CORRECT ABOUT OF INSULIN. TANDEM TECHNICAL SUPPORT HAD THE CUSTOMER PERFORM A SYSTEM CHECK USING THE CURRENT SUPPLIES ON THE PUMP AND THE PUMP WAS FOUND TO BE OPERATING AS EXPECTED. TANDEM TECHNICAL SUPPORT RECOMMENDED THAT THE CUSTOMER DISCUSS THE BG LEVEL WITH THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482132 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other