BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 18112783 · Received November 10, 2023

    Report

    Report Number
    3013756811-2023-155547
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 10, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE TANDEM PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. THE CARTRIDGE IS INDICATED AS A RESERVOIR FOR THE DELIVERY OF RAPID-ACTING INSULIN WITH THE T:SLIM PUMP. HUMALOG® AND NOVOLOG® HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC. AND FOUND TO BE SAFE FOR USE IN THE T:SLIM PUMP. HUMALOG® WAS TESTED FOR UP TO 48 HOURS AS LABELED, NOVOLOG® WAS TESTED FOR UP TO 72 HOURS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, THE CUSTOMER DID NOT PERFORM THE AIR REMOVAL STEP AND USED THE CARTRIDGE BEYOND LABELING. CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832521 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female