BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974289 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89135
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HIS INSULIN PUMP WAS ALARMING AND UPON INQUIRING FURTHER, IT WAS DISCOVER THAT HE HAD BEEN INVOLVED IN AN AUTOMOBILE ACCIDENT THAT WAS NOT DIABETES RELATED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO PERFORM A FIXED PRIME. CUSTOMER STATES THE INSULIN DID NOT EXIT AND THE DEVICE ALARMED NO DELIVERY. NEXT, CUSTOMER WAS ASKED TO REMOVE RESERVOIR AND PERFORM A MANUAL PRIME. CUSTOMER STATES THE INSULIN DID EXIT AND THE DEVICE DID NOT ALARM NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 122 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449991 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR