BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR, PRDGM

    MDR report key: 721921 · Received May 31, 2006

    Report

    Report Number
    2032227-2006-00988
    Event Type
    Malfunction
    Date Received
    May 31, 2006
    Date of Event
    May 16, 2006
    Report Date
    May 16, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HER RESERVOIR LEAKED OUT FROM THE BACK OF O-RINGS INTO HER RESERVOIR COMPARTMENT. ADVISED CUSTOMER TO SAVE RESERVOIRS AND SEND THEM BACK TO MINIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR, PRDGM RESERVOIR LZG MEDTRONIC MINIMED MMT-326A *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR