BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8860118 · Received August 5, 2019

    Report

    Report Number
    3013756811-2019-47285
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    June 22, 2019
    Report Date
    August 5, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BASAL IQ USER GUIDE STATES ¿HUMALOG® OR NOVOLOG® . ONLY HUMALOG® AND NOVOLOG® HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE VERY HIGH OR A VERY LOW BLOOD GLUCOSE.¿ 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 INTERMITTENT MINIMUM FILL NOTIFICATIONS OCCURRED AFTER FILLING A CARTRIDGE WITH 150-225 UNITS OF INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 271 MG/DL. REPORTEDLY, CUSTOMER WAS USING OFF LABEL INSULIN IN THE CARTRIDGES. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON LABELED INSULIN USE. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654517 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 M199322 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR