BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9995867 · Received April 24, 2020

    Report

    Report Number
    3013756811-2020-39983
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    March 30, 2020
    Report Date
    April 24, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING THE FILL PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200-215 MG/DL. A SYRINGE NEEDLE CHANGE WAS PERFORMED RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461192 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF