BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8905483 · Received August 19, 2019

    Report

    Report Number
    3013756811-2019-50665
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 27, 2019
    Report Date
    August 19, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP USER GUIDE STATES DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ALARM 29 ISSUE WAS VERIFIED AND THE ALLEGED CGM ERROR COULD NOT BE VERIFIED. HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 29) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. REPORTEDLY, THE CARTRIDGES WERE BEING REUSED. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE LABELING. ADDITIONALLY, THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET TO RESOLVE THE REPORTED ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700345 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