BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9330372 · Received November 15, 2019

    Report

    Report Number
    3013756811-2019-79271
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 15, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS BETWEEN 233-480 MG/DL WITH KETONE LEVEL IDENTIFIED BY HEALTHCARE PROVIDER AS BEING DANGEROUS. CAUSE OF ELEVATED BG WAS UNKNOWN. CUSTOMER CHANGED SUPPLIES AND WENT TO THE EMERGENCY ROOM (ER) AND AN INSULIN DRIP WAS ADMINISTERED. CUSTOMER WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. AT THE TIME OF THE REPORT, CUSTOMER STATED THAT THEY WOULD BE DISCHARGED ON (B)(6) 2019; HOWEVER, CUSTOMER DID NOT RESPOND TO FOLLOW UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124473 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 24 YR Hospitalization| L| R INSULIN: NOVOLOG / NOVORAPID