BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3823676 · Received February 20, 2014

    Report

    Report Number
    3007981285-2014-00064
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 21, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Removal / Correction Number
    Z-0827-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS HOME SICK AND HAD EXPERIENCED ELEVATED BG'S (400-500'S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106670 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M001456

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR