BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11003548 · Received December 14, 2020

    Report

    Report Number
    3013756811-2020-141910
    Event Type
    Injury
    Date Received
    December 14, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 14, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY WAS INTERMITTENTLY DEPLETING QUICKLY RESULTING IN PUMP SHUTTING DOWN MULTIPLE TIMES. THE CUSTOMER¿S BLOOD GLUCOSE WAS 250-529 MG/DL WITH MODERATE KETONES. REPORTEDLY, THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS BG LEVEL, AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467916 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 14 YR Other