BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161757 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01680
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIS BLOOD GLUCOSE LEVELS GOING LOW FOR THE PAST THREE DAYS. THE CUSTOMER'S MOTHER TOOK HER TO THE EMERGENCY ROOM TO SPEAK WITH THE DOCTOR ABOUT THE FREQUENT LOW BLOOD GLUCOSE LEVELS, AND THE DOCTOR FELT THAT THE INSULIN PUMP WAS MALFUNCTIONING. THE CUSTOMER AND DOCTOR BOTH WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization