BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3023033 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-92143
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    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 HOSPITALIZED DUE TO KETONES AND HIGH BLOOD GLUCOSE OF 496MG/DL AND THE DOCTOR WANTS TO BE DISCONNECTED FROM THE INSULIN PUMP FOR THREE DAYS. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND A NO DELIVERY ALARM. THE CALLER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. WHEN THEY RECEIVED THE TUBING CLAMP THE FATHER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND PASSED. DURING TROUBLESHOOTING THE INSULIN PUMP ALARMED NO DELIVERY. INSTRUCTED THE MOTHER TO REMOVE THE CANNULA AND IT WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126253 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 7 YR Hospitalization