BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED PARADIGM RESERVOIR - MMT 332A

    MDR report key: 956501 · Received November 28, 2007

    Report

    Report Number
    MW5004550
    Event Type
    Other
    Date Received
    November 28, 2007
    Date of Event
    October 12, 2007
    Report Date
    November 28, 2007
    Manufacturer
    MEDTRONIC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING OF DEFECTIVE MEDTRONICS 3ML PARADIGM RESERVOIRS. THESE RESERVOIRS ARE USED WITH THE MEDTRONICS PARADIGM SILHOUETTE CANNULAS AND MEDTRONIC MINIMED INSULIN PUMP. USER REPORTED THAT THE RESERVOIRS DID NOT CONNECT TIGHTLY WITH THE CANNULAS AND AS A RESULT BLOOD SUGARS INCREASED DUE TO THE INSULIN NOT BEING DELIVERED. THE USER REPORTED THAT HE SENT BACK THREE SEPARATE BATCHES OF RESERVOIRS TO MEDTRONICS TO BE REPLACED. THE RESERVOIR PROBLEM CONTINUED TO HAPPEN ACROSS THREE DIFFERENT BATCHES. USER HAS REPLACED THE MEDTRONICS SYSTEM WITH A DIFFERENT MFR'S INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM RESERVOIR - MMT 332A NONE FMF MEDTRONIC MMT-332A GH2707522

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other