BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6900520 · Received September 28, 2017

    Report

    Report Number
    3007981285-2017-27868
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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)(6) 2017, THE CONTACT REPORTED THAT THE HIGH BLOOD GLUCOSE HAD BEEN RESOLVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL HAD BEEN RISING (200-474 MG/DL) WITH A TRACE AMOUNTS OF KETONES. A BOLUS WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CAUSE OF THE HIGH BG WAS NOT KNOWN. THE CONTACT DECLINED TANDEM CUSTOMER TECHNICAL SUPPORT'S (CTS) OFFER TO TROUBLESHOOT. CTS ADVISED THE CONTACT TO DISCUSS THE HIGH BG WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681520 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other