BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6101129 · Received November 14, 2016

    Report

    Report Number
    3007981285-2016-19408
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 25, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (250-HIGHEST METER READING) AND HAS BEEN UNABLE TO LOWER THE BG FROM 250 MG/DL. THE CUSTOMER THOUGHT THAT THE PUMP WAS DELIVERING LESS INSULIN THAN IT SHOULD BASED ON THE PUMP SETTINGS. INSULIN INJECTIONS WERE USED TO ADDRESS THE BG LEVEL. THE CUSTOMER HAS BEEN IN CONTACT WITH A HEALTHCARE PROVIDER. THE CUSTOMER WAS TO USE A DEMO PUMP AND INSULIN INJECTIONS TO MANAGE DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750301 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other INSULIN: NOVOLOG, INFUSION SET: ACCUCHECK, CONTACT