BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED RESERVOIR

    MDR report key: 499562 · Received December 5, 2003

    Report

    Report Number
    2032227-2003-01321
    Event Type
    Malfunction
    Date Received
    December 5, 2003
    Date of Event
    September 11, 2003
    Report Date
    November 5, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD BEEN EXPERIENCING HBG'S AND WANTED TO TROUBLESHOOT ON THE PUMP. WHILE RUNNING THE HIGH PRESSURE TEST, THE CUSTOMER REPORTED THAT THERE WAS INSULIN LEAKING THROUGH THE O RINGS ON THE RESERVOIR. AT THAT TIME, THE CUSTOMER WAS TOLD THAT REPLACEMENTS WILL BE SENT AND FOR THE CUSTOMER TO CHANGE OUT ENTIRE SET. IT WAS INDICATED THAT THE CUSTOMER TOOK A MANUAL INJECTION TO TREAT HBG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED RESERVOIR RESERVOIR LZG MINIMED INC. MMT-103 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR