BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3850406 · Received May 15, 2014

    Report

    Report Number
    3007981285-2014-00660
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING IT WAS IDENTIFIED PT HAD ENTERED 80 CARBS AND HAD NOT EATEN ENOUGH TO COVER WHAT FOR INSULIN DELIVERY.

    Description of Event or Problem · 1

    RECEIVED INFO STATING PT WAS EXPERIENCING LOW BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291438 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other