BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972270 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88668
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY. CUSTOMER STATES THAT THEY HAVE CHANGE THE RESERVOIR AND INFUSION SET, YET ISSUE HAS CONTINUED. 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. ADVISED CUSTOMER THE ISSUE MIGHT BE AN OCCLUDED INSERTION SITE. ADVISED CUSTOMER TO REPLACE RESERVOIR AND SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 479 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447692 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR