BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 8865700 · Received August 6, 2019

    Report

    Report Number
    3013756811-2019-45661
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 6, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT WAS SUBMITTED IN ERROR. THE DEVICE (POWER ADAPTER) IS NOT MARKETED IN THE UNITED STATES BY THE MANUFACTURER AND IS NOT SAME/SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES BY THE MANUFACTURER.

    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 THE CUSTOMER ATTEMPTED TO REMOVE THE WALL ADAPTER FROM THE OUTLET, THE ADAPTER BROKE RESULTING IN BEING UNABLE TO CHARGE THE PUMP WITH THE WALL ADAPTER. A REPLACEMENT ADAPTER WAS SENT TO THE CUSTOMER. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660299 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