BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13288610 · Received January 19, 2022

    Report

    Report Number
    3013756811-2022-06288
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 19, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 PUMP WAS INTERMITTENTLY NOT DELIVERING BOLUSES AS INTENDED. PUMP DATA REVIEW BY TANDEM TECHNICAL SUPPORT CONFIRMED THE PUMP WAS FUNCTIONING AS INTENDED; HOWEVER CUSTOMER MAINTAINED THAT THE PUMP WAS NOT FUNCTIONING PROPERLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 180-388 MG/DL; CAUSE WAS UNKNOWN. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101617 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 67 YR Female INSULIN: NOVOLOG.INFUSION SET: TRUSTEEL.