BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5535357 · Received March 30, 2016

    Report

    Report Number
    3007981285-2016-74194
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 8, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER BLOOD GLUCOSE WAS 250-380 MG/DL. THE CUSTOMER ADMINISTERED A MANUAL INJECTION. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT(CTS), CTS DETERMINED THAT THE PUMP FUNCTIONED AS INTENDED. REPORTEDLY, THE CONTACTED STATED THAT THE SITE WAS NOT CHANGED SINCE THE REPORTED EVENT. FOLLOWUP CALL WITH CTS THE CONTACT REPORTED THAT THE CUSTOMER'S BG HAVE STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190278 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other INFUSION SET: INSET INSULIN: NOVOLOG