BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6910598 · Received October 3, 2017

    Report

    Report Number
    3007981285-2017-28215
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 28, 2017
    Report Date
    October 3, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. ON (B)(4) 2019, A TANDEM CLINICAL DIABETES SPECIALIST REPORTED THAT AFTER THE PUMP BASAL SETTING WAS ADJUSTED, THE CUSTOMER'S BLOOD GLUCOSE LEVEL HAD STABILIZED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (200-396 MG/DL). A CORRECTION BOLUS AND INSULIN INJECTIONS WERE USED TO ADDRESS THE BG LEVEL. THE CAUSE OF THE HIGH BG WAS NOT KNOWN. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO DISCUSS THE HIGH BG WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691049 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other INSULIN: HUMALOG, INFUSION SET: COMFORT SHORT