BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9083155 · Received September 18, 2019

    Report

    Report Number
    3013756811-2019-58432
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 18, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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 WHEN ATTEMPTING TO CHARGE THE PUMP WITH THE ADAPTER THE ADAPTER "EXPLODED" RESULTING IN DAMAGE TO THE CHARGING SECTION OF THE PUMP. CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL RANGING BETWEEN 183-183 MG/DL AND BURNS ON HANDS. MEDICAL INTERVENTION WAS NOT REQUIRED FOR THE BURNS. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877795 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other