BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4528723 · Received February 19, 2015

    Report

    Report Number
    3004209178-2015-95702
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 9, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED BATTERY OUT LIMIT ALARM NOTED. THE INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BATTERY OUT LIMIT ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 198 MG/DL. CUSTOMER STATED THAT HE HAD CHANGED THE BATTERY YESTERDAY AND RECEIVED THE ALARM TODAY. CUSTOMER STATED THAT THE BATTERIES WERE NOT OUT OF THE PUMP GREATER THAN THE DURATION ALLOWED BY THE PUMP. CUSTOMER TESTED WITH A NEW A BATTERY AND THE PUMP HAD A BATTERY OUT LIMIT ALARM. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO FURTHER ASSISTANCE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119124 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR