BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11252036 · Received January 29, 2021

    Report

    Report Number
    3013756811-2021-10182
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 6, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION, TIME, AND DATE ISSUES WERE VERIFIED, AND A DIFFERENT ISSUE WAS IDENTIFIED (LEAK RATE TEST - OUT OF SPECIFICATIONS).

    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 THE PUMP TOUCH SCREEN FROZE AND WAS UNRESPONSIVE. FOLLOWING THIS, AN UNDEFINED MALFUNCTION OCCURRED AND PUMP TIME AND DATE WERE FOUND TO BE INCORRECT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 172-180 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149297 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 23 YR