BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233529 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48883
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 HIGH BLOOD GLUCOSE LEVELS OF 451 MG/DL. THE CUSTOMER REPORTED MULTIPLE FAILED BATTERY TEST ALARMS FROM THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A BATTERY OUT LIMIT ALARM FROM THE INSULIN PUMP. THE CUSTOMER REPORTED USING NEW BATTERIES ON THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS INSTRUCTED TO CHECK THE CONTACTS ON THE BATTERY CAP FOR DAMAGE. IT WAS REPORTED THAT THE CONTACTS WERE NOT MISSING OR DAMAGED. THE CUSTOMER WAS ADVISED TO INSPECT THE BATTERY COMPARTMENT AND SPRING FOR CORROSION OR DAMAGE. IT WAS REPORTED THAT NEITHER THE BATTERY COMPARTMENT NOR SPRING WERE DAMAGED OR CORRODED. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP UNTIL A NEW BATTERY CAP FOR THE INSULIN PUMP IS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713820 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR