BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3000661 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-91811
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 600MG/DL AND KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED. THE FATHER STATED THAT THE CUSTOMER WAS OFF THE INSULIN PUMP SINCE (B)(6) 2013 AND HIS BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTIONS. THE FATHER STATED THAT THE SETTINGS WERE INCREASED, AND HIS BLOOD GLUCOSE IS FINE, BUT THE KETONES ARE STILL HIGH. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. THE MOTHER CALLED AND STATED THAT HER SON WILL BE OFF THE INSULIN PUMP FOR A WHILE DUE TO ISSUES WITH HIS INFUSION SETS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104205 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization