BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6366332 · Received February 28, 2017

    Report

    Report Number
    3007981285-2017-05384
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (200-260 MG/DL). THE CUSTOMER THOUGHT THAT THE PUMP WAS NOT DELIVERING INSULIN. A PUMP SYSTEM CHECK WAS PERFORMED ON TWO DIFFERENT DAYS AND NO DEVICE ISSUES WERE FOUND. THE CUSTOMER REVERTED TO USING A NON-TANDEM PUMP TO MANAGE DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148606 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other INSULIN: NOVOLOG, INFUSION SET: CONTACT DETACH