BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10785312 · Received November 4, 2020

    Report

    Report Number
    3013756811-2020-121586
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 4, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND IT WAS DISCOVERED OCCLUSION WAS CAUSED BY A BLOCKAGE IN THE CARTRIDGE. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE WAS 182-220 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248073 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 20 YR INSULIN: NOVOLOG/NOVORAPID