BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDAM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3905207 · Received May 29, 2014

    Report

    Report Number
    3007981285-2014-00858
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PATIENT IS (B)(6) YEARS OLD. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT HAS BEEN EXPERIENCING HIGH BG'S (500-600 MG/DL). AS PER REPORTER SHE DOES NOT BELIEVE ISSUE IS PUMP RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317276 TANDAM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR