BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9845109 · Received March 17, 2020

    Report

    Report Number
    3013756811-2020-27181
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    January 15, 2020
    Report Date
    March 17, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM X2 BASAL IQ USER GUIDE STATES: DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR U-100 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.

    Additional Manufacturer Narrative · 1

    THE T:SLIM X2 WITH CIQ TECHNOLOGY USER GUIDE STATES: DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR U-100 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. ALSO PER TANDEM¿S USER GUIDE: "RESIDUAL INSULIN REMAINING IN THE CARTRIDGE (UNUSABLE)." 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 OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED SUPPLIES TO ADDRESS THE OCCLUSION ALARMS. CUSTOMER REPORTED USING APIDRA INSULIN, AND FILLING CARTRIDGES WITH THE RESIDUAL INSULIN FROM PREVIOUSLY USED CARTRIDGES. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT APIDRA IS OFF-LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305813 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR