BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920038 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86517
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    CUSTOMER'S WIFE REPORTED HIGH BLOOD GLUCOSE LEVELS OF 480 MG/DL AND HAS TREATED WITH A MANUAL INJECTION. CUSTOMER ALSO REPORTED HOSPITALIZATION DUE TO A LIGHT STROKE. CUSTOMER STATED THAT HE FELT NAUSEATED AND HAD A HEADACHE PRIOR TO THE HOSPITALIZATION. CUSTOMER WAS RELEASED FROM THE HOSPITAL AFTER HIS HEART RATES CAME DOWN. TROUBLESHOOTING WAS PERFORMED, AND DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. THE HIGH PRESSURE TEST WAS ALSO PERFORMED TWICE AND PASSED THE SECOND TIME. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396641 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization