BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED PARADIGM SILHOUETTE INSULIN INFUSION

    MDR report key: 1942101 · Received December 25, 2010

    Report

    Report Number
    MW5018712
    Event Type
    Malfunction
    Date Received
    December 25, 2010
    Date of Event
    December 25, 2010
    Report Date
    December 25, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    USING MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MULTIPLE OCCLUSION ALARMS DUE TO INSULIN NOT BEING ABLE TO GO THROUGH TUBING OR INFUSION SET PROPERLY. PUMP STOPS DELIVERING INSULIN. HAVE HAD MULTIPLE ONGOING PROBLEMS WITH THIS INFUSION SET FOR OVER 1 YR, CONTINUE TO HAVE THE TUBING OCCLUDE AND STOP GIVING INSULIN. SUPPORT LINE FOR COMPANY NOT VERY HELPFUL AND EFFORTS TO DISCUSS AND RECEIVE HELP FROM THE COMPANY HAVE BEEN DIFFICULT. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: INSULIN DEPENDENT DIABETES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM SILHOUETTE INSULIN INFUSION SILHOUETTE INFUSION SET FPA MEDTRONIC MMT-379A 622076

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other