BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3770473 · Received February 18, 2014

    Report

    Report Number
    3007981285-2014-00045
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 16, 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 INFO STATING PT EXPERIENCED HIGH BG'S. AS PER REPORTER, HE DOES NOT BELIEVE THE CAUSE OF HIGH BG'S WERE PUMP OR CARTRIDGE RELATED AS PT WAS HOSPITALIZED DUR TO ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102290 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002027

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR