BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13541982 · Received February 16, 2022

    Report

    Report Number
    3013756811-2022-18372
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 16, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND A BLOOD GLUCOSE (BG) LEVEL OF 160-500 MG/DL RANGE. CUSTOMER WAS TREATED; HOWEVER, CUSTOMER COULD NOT RECALL SPECIFIC TREATMENT RECEIVED. THE CUSTOMER WAS DISCHARGED ON (B)(6) 2022 WITH NO PERMANENT DAMAGE. REPORTEDLY, THE CUSTOMER HAD FOOD POISONING AND PUMP SETTINGS WERE RECENTLY ADJUSTED TO LEVELS WHICH THE CUSTOMER SUSPECTED WERE INCORRECT. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH A HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8802 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 48 YR Female Hospitalization| R INSULIN TYPE: HUMALOG