BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8806910 · Received July 19, 2019

    Report

    Report Number
    3013756811-2019-41588
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 19, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007301
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CLEAR PLASTIC MATERIAL AT THE FILL SEPTUM PORT WITH MULTIPLE CARTRIDGES. THE CUSTOMER WAS UNABLE TO INSERT THE NEEDLE INTO THE FILL PORT OF THE CARTRIDGE. A NEW CARTRIDGE WAS SUCCESSFULLY LOADED, AND CUSTOMER RESUMED INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 242 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600854 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG/NOVORAP