BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9272017 · Received November 4, 2019

    Report

    Report Number
    3013756811-2019-75132
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 12, 2019
    Report Date
    November 4, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007981
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED ISSUE WAS VERIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT ALTITUDE ALARMS OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. CUSTOMER¿S BLOOD GLUCOSE WAS 140-283 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065659 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 55 YR