BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 16432669 · Received February 23, 2023

    Report

    Report Number
    3013756811-2023-23340
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 3, 2023
    Report Date
    June 2, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THE CUSTOMER DID NOT REMOVE THE AIR FROM THE CARTRIDGE PRIOR TO FILLING THE CARTRIDGE INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE LABELING. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE AND THE INSULIN GAUGE CONTINUED TO BE INACCURATE. THE CUSTOMER CONTINUED USING THE CARTRIDGE. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 111-127 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449650 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female