BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYS

    MDR report key: 3812745 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00555
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 7, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PT WAS HOSPITALIZED DUE TO HIGH BG'S (521) AND DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267858 TANDEM T:SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R