BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3915530 · Received February 26, 2014

    Report

    Report Number
    3007981285-2014-00173
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 26, 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

    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).

    Description of Event or Problem · 1

    REC'D INFO STATING PATIENT EXPERIENCED HIGH BG'S. IT IS UNKNOWN WHICH CARTRIDGE LOT NUMBER WAS BEING USED AT THE TIME OF EVENT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117622 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002028, M001345

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR