BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3941779 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87505
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 REPORTED AN ISSUE WITH HER BATTERY AND STATED THAT HER BATTERY COMPARTMENT IS BAD AND GETS A BAD CONNECTION. CUSTOMER STATED THAT THEY HAVE DIFFICULTY REMOVING THE BATTERY CAP ON THEIR INSULIN PUMP AND ALSO REPORTED RECEIVING A NO DELIVERY ALARM. CUSTOMER ALSO MENTIONED HAVING TO CHANGE BATTERIES MORE OFTEN AND STATED THAT SOMETIMES THEIR BATTERIES LAST LESS THAN A WEEK. CUSTOMER WAS UNABLE TO TROUBLESHOOT AT THIS TIME. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 183 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419728 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 61 YR