BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8570948 · Received May 1, 2019

    Report

    Report Number
    3013756811-2019-23378
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 1, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CLEARED THE ALARMS AND RESUMED INSULIN DELIVERY. THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGING FROM 200-550 (MG/DL) AND LARGE KETONES CONSIDERED DANGEROUS. CORRECTION BOLUSES WERE DELIVERED VIA THE PUMP AND AN INFUSION SET CHANGE WAS PERFORMED TO ADDRESS BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363484 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 5 YR Life Threatening INFUSION SET: AUTOSOFT 30, INSULIN: HUMALOG