BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 8578016 · Received May 3, 2019

    Report

    Report Number
    3013756811-2019-22775
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 3, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S USER GUIDE: DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR NOVOLOG/NOVORAPID. ONLY HUMALOG AND NOVOLOG/NOVORAPID HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. 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. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 232-343 (MG/DL). CUSTOMER PERFORMED INFUSION SITE CHANGE AND RESUMED INSULIN DELIVERY. CUSTOMER WAS USING FIASP INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370716 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN: FIASP, INFUSION SET: TRUSTEEL