BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6691111 · Received July 6, 2017

    Report

    Report Number
    3007981285-2017-18297
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 10, 2017
    Report Date
    July 6, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    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 HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (250-380 MG/DL) WITH A MODERATE LEVEL OF KETONES AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED. THE CUSTOMER ACKNOWLEDGED THE INFORMATION AND HAD NO FURTHER QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470672 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other INSULIN: NOVOLOG, INFUSION SET: QUICKSET