BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 8621225 · Received May 17, 2019

    Report

    Report Number
    3013756811-2019-27652
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 17, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007967
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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 A CARTRIDGE CHANGE ERROR OCCURRED DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ABOVE 600 MG/DL. CUSTOMER DELIVERED A MANUAL INJECTION TO ADDRESS BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414697 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1000096 00853052007967

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other INFUSION SET: AUTOSOFT 90, INSULIN:NOVOLOG