BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3912843 · Received June 13, 2014

    Report

    Report Number
    3007981285-2014-01131
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. AS PER CUSTOMER NO FURTHER ASSISTANCE IS REQUIRED. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PATIENT IS (B)(6) YEARS OLD.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT HAS BEEN EXPERIENCING HIGH BG'S (411 MG/DL). PATIENT'S DOCTOR CHANGED BASAL RATE AND CARBOHYDRATE RATIO. PATIENT'S FATHER ALSO CHANGED PATIENT'S INFUSION SET, CARTRIDGE, AND INSULIN. PATIENT'S BG'S ARE NOW 140 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349761 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention