BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16068333 · Received December 29, 2022

    Report

    Report Number
    3013756811-2022-150078
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 29, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER TANDEM USER GUIDE: IF YOU DO NOT SEE DROPS, TAP FILL. THE FILL TUBING SCREEN APPEARS, REPEAT STEPS 5 AND 6 UNTIL YOU SEE 3 DROPS OF INSULIN AT THE END OF THE TUBING. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL RANGING FROM 100-538 MG/DL. CUSTOMER PERFORMED A SUPPLY CHANGE AND GAVE A CORRECTION BOLUS VIA THE PUMP TO ADDRESS THE BG LEVEL. REPORTEDLY, THE CUSTOMER WAS NOT COMPLETING THE LOAD FILL TUBING SEQUENCE PROCESS. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON THE PROPER LOAD TECHNIQUES, CUSTOMER UNDERSTOOD AND ACKNOWLEDGED. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424594 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other INSULIN: HUMALOGINFUSION SET: TRUSTEEL