BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3213954 · Received July 3, 2013

    Report

    Report Number
    3007981285-2013-00034
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED. USER GUIDE STATES: THE T:SLIM INSULIN DELIVERY SYSTEM IS INTENDED FOR THE SUBCUTANEOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSON REQUIRING INSULIN, FOR INDIVIDUALS 12 YEARS OF AGE AND GREATER.

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM THE PATIENT'S MOTHER INDICATING PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND IS ON I.V. TANDEM HAS MADE MULTIPLE ATTEMPTS TO TRY AND RETRIEVE FURTHER EVENT INFORMATION WITH NO CUSTOMER RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303676 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R