BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10696411 · Received October 19, 2020

    Report

    Report Number
    3013756811-2020-114151
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 19, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613717
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS WITH INTERMITTENT CARTRIDGES. ADDITIONALLY, INTERMITTENT MINIMUM FILL NOTIFICATIONS OCCURRED WITH CARTRIDGES AFTER THE USER FILLED THE CARTRIDGE WITH 150 UNITS OF INSULIN DURING THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE RANGED BETWEEN 250-402 MG/DL. REPORTEDLY THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166466 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00850006613717

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG| INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG