BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4792065 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58812
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 3, 2015
    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

    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

    THE CUSTOMER REPORTED VIA TELEPHONE CALL THAT THE INSULIN PUMP ALARMED FOR NO DELIVERY OF INSULIN DURING A SET CHANGE. THE BLOOD GLUCOSE READING WAS 134 MG/DL. THE CUSTOMER WAS ADVISED TO CLEAR THE ALARM, DISCONNECT FROM THE INSULIN PUMP, DISCONNECT AND RECONNECT THE TUBING AND RESERVOIR AND VERIFY THE CONNECTION WAS SECURE, AND TO MANUALLY PUSH WITH THE PLUNGER. THE CUSTOMER REPORTED THAT INSULIN DID EXIT WITH THE PLUNGER PUSH. THE CUSTOMER WAS ADVISED TO RUN A MANUAL PRIME AND REPORTED THAT INSULIN DID EXIT AND THERE WAS NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334455 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR