BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10705977 · Received October 20, 2020

    Report

    Report Number
    3013756811-2020-113464
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 27, 2020
    Report Date
    October 20, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 INTERMITTENT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BETWEEN 140-263 MG/DL. A METHOD OF BACKUP THERAPY WAS NOT PROVIDED. TANDEM TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER AND COMPLETE TROUBLESHOOTING; HOWEVER, A RESPONSE WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171089 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 75 YR