BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 8717208 · Received June 20, 2019

    Report

    Report Number
    3013756811-2019-33865
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 27, 2019
    Report Date
    June 20, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007981
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE, INTERMITTENT MALFUNCTION ALARMS OCCURRED WHILE CONNECTED TO A POWER SOURCE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 151-177 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510878 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1000096 00853052007981

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR