BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8906614 · Received August 19, 2019

    Report

    Report Number
    3013756811-2019-49541
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 29, 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
    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.

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE TEMPERATURE ALARM ISSUE WAS VERIFIED. THE ALARM 25 WAS VERIFIED IN THE VERIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED. THE TOUCH SCREEN ISSUES COULD NOT BE VERIFIED; HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED (MALFUNCTION ALARM).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCHSCREEN WAS UNRESPONSIVE, A CARTRIDGE ALARM 25 OCCURRED, AND MULTIPLE TEMPERATURE ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE TOUCHSCREEN WAS LIGHTER ON ONE SIDE. REPORTEDLY, CUSTOMER GOT THE PUMP WET WHILE PLAYING IN THE CREEK AND REPORTED WATER DAMAGE ON THE TOUCHSCREEN. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 202-285 MG/DL. CUSTOMER REVERTED TO MANUAL INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699705 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 17 YR