BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6979655 · Received October 26, 2017

    Report

    Report Number
    3007981285-2017-31739
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 29, 2017
    Report Date
    October 26, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING INTERMITTENT HIGH BLOOD GLUCOSE (BG) LEVELS (200-328 MG/DL) AND THE CAUSE WAS NOT KNOWN. A CORRECTION BOLUS WOULD BE DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER REVIEWED THE PUMP HISTORY AND CONFIRMED THAT THE BOLUSES HAD BEEN SUCCESSFULLY DELIVERED. THE CUSTOMER DECLINED TANDEM TECHNICAL SUPPORT'S (CTS) OFFER TO TROUBLESHOOT. CTS RECOMMENDED THE CUSTOMER TO DISCUSS THE HIGH BG WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759523 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other INSULIN: HUMALOG, INFUSION SET: T:90