BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5549079 · Received April 5, 2016

    Report

    Report Number
    3007981285-2016-74027
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 BY THE CONTACT THAT THE CUSTOMER HAD BEEN EXPERIENCING BLOOD GLUCOSE (BG) LEVELS IN THE 220-454 MG/DL RANGE. INSULIN INJECTIONS AND BOLUSES OF INSULIN WERE USED TO ADDRESS THE BG LEVEL. THE CONTACT DID STATE ONE MORNING, THE CUSTOMER FORGOT TO DELIVER A BOLUS FOR A MEAL. THE CAUSE OF THE OTHER HIGH BG LEVELS WAS NOT KNOWN; THERE WAS NO REPORTED DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202396 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other