BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8983442 · Received September 10, 2019

    Report

    Report Number
    3013756811-2019-62151
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    June 11, 2019
    Report Date
    September 10, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007301
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED; HOWEVER, EVALUATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING A CARTRIDGE WITH INSULIN. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150-347 MG/DL. CUSTOMER REVERTED TO MANUAL INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779376 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 M205167 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR