BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14470737 · Received May 23, 2022

    Report

    Report Number
    3013756811-2022-54454
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 4, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER THE TANDEM USER GUIDE: 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. ADDITIONALLY, INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. INSULIN THAT HAS BEEN EXPOSED TO CONDITIONS OUTSIDE OF THE MANUFACTURER¿S RECOMMENDED RANGES CAN AFFECT THE SAFETY AND PERFORMANCE OF THE PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER HAD BEEN USING COLD FIASP INSULIN WITHIN THE PUMP SUPPLIES. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT FIASP INSULIN IS OFF LABEL PER THE USER GUIDE. CUSTOMER PERFORMED A SUPPLY CHANGE TO ADDRESS OCCLUSION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 356 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552775 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 W0319642 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female INFUSION SET: TRUSTEELINSULIN: FIASP