BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241465 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50516
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 HAD A HIGH BLOOD GLUCOSE OF 375 MG/DL. NO DELIVERY TROUBLESHOOTING DURING BOLUS DELIVERY WAS GONE OVER AND THE LACK OF DELIVERY HAD BEEN DUE TO THE EMPTY RESERVOIR. THE CUSTOMER WAS PROVIDED ASSISTANCE WITH COMPLETING A SET CHANGE, FOLLOWING THE EMPTY RESERVOIR ALERT. THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED AGAIN AND FOUND TO BE 415 MG/DL AND A WALK-THROUGH OF TREATMENT WITH THE INSULIN PUMP WAS PROVIDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721876 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR