BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780887 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57563
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    THE CUSTOMER'S HUSBAND REPORTED THAT THE CUSTOMER WAS ATTEMPTING TO SET THE INSULIN PUMP BUT THAT THE INSULIN PUMP WOULD NOT RETRACT. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER'S HUSBAND EXPLAINED THAT THE INSULIN PUMP ALARMED NO DELIVERY AND NOTIFIED THE CUSTOMER OF A MISSED BOLUS. THE CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE NO DELIVERY ALARM. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326840 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR