BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6684655 · Received July 3, 2017

    Report

    Report Number
    3007981285-2017-18058
    Event Type
    Injury
    Date Received
    July 3, 2017
    Date of Event
    June 8, 2017
    Report Date
    July 3, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MULTIPLE, INTERMITTENT ALTITUDE ALARMS OCCURRED. THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGING BETWEEN 231-396 MG/DL AND TRACE LEVELS OF KETONES. CORRECTION BOLUSES VIA THE PUMP WERE DELIVERED AND MANUAL INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. INSULIN DELIVERIES WERE RESUMED AFTER EACH OF THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464609 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other INFUSION SET: INSET, INSULIN: HUMALOG