BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3893954 · Received June 12, 2014

    Report

    Report Number
    3007981285-2014-01127
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 13, 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. AS PER CUSTOMER NO FURTHER ASSISTANCE IS REQUIRED. SHOULD NEW INFO BECOMES AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING PATIENT WAS HOSPITALIZED DUE TO DKA AND A RESPIRATORY INFECTION. PATIENT WAS RELEASED ON 04/25/2014. PT WAS GIVEN SUBCUTANEOUS INSULIN DURING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348888 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R