BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6858746 · Received September 12, 2017

    Report

    Report Number
    3007981285-2017-26200
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    August 19, 2017
    Report Date
    September 12, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HIGH BLOOD GLUCOSE (BG) LEVELS (200-445 MG/DL). THE INFUSION SETS WERE CHANGED MULTIPLE TIMES AND THE CUSTOMER'S PARENT ADMINISTERED AN INSULIN INJECTION TO ADDRESS THE BG LEVEL. THE CAUSE OF THE HIGH BG WAS NOT KNOWN. THERE WAS NO CANNULA DAMAGE OBSERVED; HOWEVER, THE CONTACT REPORTED THAT THE TYPE OF INFUSION SET USED WAS TO BE CHANGED AS THE CUSTOMER WAS VERY LEAN. THE CUSTOMER REPORTED THAT THE PUMP HISTORY READ "N/A" AND THOUGHT THAT MEANT TO CHANGE OUT THE INFUSION SET. AS THE CONTACT DID NOT HAVE THE PUMP AT THE TIME OF THE REPORT, A PUMP SYSTEM CHECK WAS UNABLE TO BE PERFORMED AND THE PUMP HISTORY COULD NOT BE REVIEWED. ALTHOUGH REQUESTED, THE CONTACT DID NOT CALL BACK TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639376 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention INFUSION SET: T:90, INSULIN: NOVOLOG