BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5987140 · Received September 29, 2016

    Report

    Report Number
    3007981285-2016-11284
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    September 3, 2016
    Report Date
    September 7, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSIONS. THE CUSTOMER CHANGED OUT THE SUPPLIES ON THE PUMP MULTIPLE TIMES. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 200-235 MG/DL. A CORRECTION BOLUS AND INSULIN INJECTIONS WERE USED TO ADDRESS THE BG LEVEL. THE CUSTOMER WAS TO USE INSULIN INJECTIONS TO MANAGE DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640009 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M018252

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN: NOVOLOG, INFUSION SET: INSET