BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2781598 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-89995
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL, AND HE WAS TREATED WITH AN INSULIN DRIP AND FAST ACTING SHOT OF INSULIN. IT WAS STATED THAT THE DOCTOR BELIEVES THE INSULIN PUMP WAS MALFUNCTIONING. THE MOTHER STATED T HAT POSSIBLE CHANGES MAY HAVE BEEN AFFECTED SINCE HE IS ELEVEN YEARS OLD. ADVISED THE CALLER TO CONTACT US IF THE CUSTOMER'S BLOOD GLUCOSE RUNS HIGH FOR NO APPARENT REASON. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization