BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8552872 · Received April 25, 2019

    Report

    Report Number
    3013756811-2019-20829
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 25, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM X2G6 USER GUIDE STATES: DO NOT USE ANY OTHER INSULIN WITH YOUR PUMP OTHER THAN U-100 HUMALOG OR NOVOLOG. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. 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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. INFUSION SET SITE CHANGES WERE PERFORMED TO RESOLVE THE PAST OCCLUSIONS. A SYSTEM CHECK WAS PERFORMED FOR THE CURRENT OCCLUSION AND THE OCCLUSION WAS FOUND WITHIN THE INFUSION SET TUBING. REPORTEDLY, THE CUSTOMER USES FIASP INSULIN WITHIN THE PUMP SUPPLIES. AN INFUSION SET CHANGE WAS PERFORMED RESOLVING THE CURRENT OCCLUSION. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 200-431 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345612 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 32 YR