BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC PARADIGM QUICK-SET INFUSION SET

    MDR report key: 1431467 · Received July 25, 2009

    Report

    Report Number
    MW5012162
    Event Type
    Injury
    Date Received
    July 25, 2009
    Date of Event
    July 14, 2009
    Report Date
    July 25, 2009
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXTREME LOW BLOOD GLUCOSE MOST LIKELY BECAUSE OF USING MEDTRONIC QUICK-SET PARADIGM INFUSION SET WITH MINIMED INSULIN PUMP. THE INFUSION SET I LATER DISCOVERED TO BE FAULTY; THOSE PARTICULAR LOT NUMBERS ARE BEING RECALLED BY MEDTRONICS. THIS HAPPENED ON AN AIRPLANE INFLIGHT. LATER, I DISCOVERED THAT "A RAPID CHANGE IN AIR PRESSURE MAY CAUSE A SIGNIFICANT OVER DELIVERY OF INSULIN...[DURING] AN INCREASE IN ALTITUDE WHEN AN AIRPLANE IS TAKING OFF..." DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: INSULIN DEPEND. DIABETIC USING PUMP THERAPY TO CONTROL BLOOD. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PARADIGM QUICK-SET INFUSION SET QUICK-SET INFUSION SET FOR MINIMED INSULIN PUMP FPA MEDTRONIC MINIMED, INC. MMT 397 8 PARADIGM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other RESERVOIR| MINIMED INSULIN PUMP