BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9250362 · Received October 29, 2019

    Report

    Report Number
    3013756811-2019-75194
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    October 6, 2019
    Report Date
    October 29, 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 THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 40-46 MG/DL. THE CAUSE FOR LOW BG LEVEL WAS UNKNOWN; HOWEVER, THE HOSPITAL ALLEGED ISSUE TO BE DUE TO THE PUMP. CUSTOMER CONTACTED THE HOSPITAL FOR GUIDANCE TO TREAT LOW BG, AND WAS NOT ADMITTED TO THE HOSPITAL. A TEMPORARY BASAL RATE WAS SET, CUSTOMER DISCONNECTED FROM THE PUMP, AND CUSTOMER CONSUMED 83 GRAMS OF CARBOHYDRATES TO ADDRESS LOW BG LEVEL. AT THE TIME OF THE REPORT, CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 182-183 MG/DL, AND CUSTOMER WAS ¿OK¿. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH CUSTOMER¿S HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043374 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 Required Intervention