BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8647415 · Received May 28, 2019

    Report

    Report Number
    3013756811-2019-29584
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 5, 2019
    Report Date
    May 28, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 MULTIPLE MINIMUM FILL NOTIFICATIONS OCCURRED AFTER FILLING A CARTRIDGE WITH 200 UNITS OF INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 190 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440481 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR