BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVEY SYSTEM

    MDR report key: 3911666 · Received May 28, 2014

    Report

    Report Number
    3007981285-2014-00837
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFO BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING PT WAS HOSPITALIZED FOR DKA AND RESPIRATORY INFECTION. PT WAS TREATED WITH INSULIN DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314614 TANDEM T:SLIM INSULIN DELIVEY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R