BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARADIGM SILHOUETTE

    MDR report key: 823313 · Received February 20, 2007

    Report

    Report Number
    MW1042081
    Event Type
    Other
    Date Received
    February 20, 2007
    Date of Event
    February 5, 2007
    Report Date
    February 13, 2007
    Manufacturer
    UNOMEDICAL ALS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT USED MEDTRONIC PARADIGM INSULIN INFUSION PUMP. WITH NEW BATCH OF "SILHOUETTE" INFUSION SETS, NEEDLE AT PROXIMAL END IS NOT LONG ENOUGH TO FULLY PENETRATE RUBBER SEAL ON INSULIN RESERVOIR CYLINDER, PARTIALLY PREVENTING DELIVERY OF INSULIN TO PT, CAUSING, HIGH BLOOD SUGAR - PATIENT SELF TREATED WITH SUPPLEMENTAL SUBCUTANEOUS INSULIN SHOTS. DISTRIBUTED BY: MEDTRONIC MINIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM SILHOUETTE INFUSION SET FPA UNOMEDICAL ALS MMT-377 585869

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other