BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6061139 · Received October 27, 2016

    Report

    Report Number
    3007981285-2016-16212
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 8, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 A BLOOD GLUCOSE (BG) OF 58 MG/DL AND CARBOHYDRATES WERE CONSUMED TO ADDRESS THE BG LEVEL. THE CUSTOMER STATED THAT THE LOW BG WAS NOT CAUSED BY THE PUMP OR SUPPLIES; HOWEVER, A CAUSE WAS NOT REPORTED. THE CUSTOMER RECEIVED 2 OCCLUSION ALARMS. THE CUSTOMER CHANGED THE INFUSION SET SITE. THE CUSTOMER'S BG LEVEL WAS 477 MG/DL. CORRECTION BOLUSES WERE DELIVERED TO ADDRESS THE BG LEVEL AND IF NEEDED, INSULIN INJECTIONS WOULD BE USED. THE CUSTOMER REPORTED THAT THE INSULIN APPEARED TO BE GEL-LIKE. THE CUSTOMER WAS TO CHANGE ALL OF THE PUMP SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711832 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M018456

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other INSULIN: NOVOLOG