BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12202578 · Received July 21, 2021

    Report

    Report Number
    3013756811-2021-77774
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 21, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE (BG) WAS 210-412 MG/DL AND CUSTOMER WAS VOMITING. CUSTOMER ATTEMPTED TO DELIVER A 5 UNIT BOLUS VIA PUMP TO ADDRESS BG. CUSTOMER DID NOT HAVE INSULIN TO ADMINISTER MANUAL INJECTIONS AND WENT TO THE EMERGENCY ROOM (ER). CUSTOMER WAS IN DIABETIC KETOACIDOSIS (DKA). CUSTOMER WAS ADMITTED AND TREATED WITH INTRAVENOUS INSULIN AND SALINE (5 UNITS OF INSULIN PER HOUR). ELEVATED BG/DKA WERE RESOLVED. AFTER 2 DAYS, CUSTOMER WAS DISCHARGED WITH NO INJURY. AS PUMP SUPPLIES WERE DISCARDED, CAUSE OF OCCLUSION COULD NOT BE DETERMINED. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND PUMP WAS FOUND TO BE FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102979 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R INSULIN: NOVORAPID, INFUSION SET: TRUSTEEL