BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6766712 · Received August 4, 2017

    Report

    Report Number
    3007981285-2017-21859
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 4, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING, INTERMITTENT HIGH BLOOD GLUCOSE (BG) LEVELS (250-382 MG/DL). THE PUMP SUPPLIES HAD BEEN CHANGED. THE CAUSE OF THE HIGH BG WAS NOT KNOWN. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED USING THE CURRENT SUPPLIES ON THE PUMP. THE CONTACT DECLINED TO REMOVED THE INFUSION SET SITE AT THE TIME OF THE REPORT. THE CONTACT THOUGHT THAT THE PUMP SETTINGS POSSIBLY NEEDED TO BE ADJUSTED AND THE CUSTOMER'S TRAINER WAS TO BE CONTACTED. THE CONTACT DECLINED TANDEM TECHNICAL SUPPORT'S OFFER TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547651 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other INSULIN: HUMALOG, INFUSION SET: INSET