BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,INSULIN,512 NA SMOKE

    MDR report key: 594161 · Received June 11, 2004

    Report

    Report Number
    2032227-2004-00867
    Event Type
    Malfunction
    Date Received
    June 11, 2004
    Date of Event
    May 13, 2004
    Report Date
    May 13, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT HAVE AN AUDIBLE TONE. IT WAS STATED THAT IF COULD NOT BE HEARD NAY AUDIO BEEP OR TONE DURING THE SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,INSULIN,512 NA SMOKE INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR