BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4223189 · Received October 27, 2014

    Report

    Report Number
    3007981285-2014-10545
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INDICATES THAT THE CUSTOMER WAS RELEASED FROM THE EMERGENCY ROOM SAME DAY. CUSTOMER WAS DOING MUCH BETTER AND BLOOD GLUCOSE LEVEL WAS STABLE. IN ADDITION, T:SLIM USER GUIDE INDICATES PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS AND GREATER; PATIENT IS (B)(6). THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER (B)(6) UNLOCKED THE PUMP SCREEN AND REQUESTED A 22.7 UNIT BOLUS THAT WAS NOT INTENDED. TWO GLUCAGON SHOTS AND CANDY WERE ADMINISTERED TO THE CUSTOMER. THE CUSTOMER WAS TAKEN TO THE HOSPITAL EMERGENCY ROOM WHERE THE CUSTOMER WAS TREATED WITH INTRAVENOUS GLUCAGON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681105 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R