BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241492 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50636
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 IS REPORTED THAT A CUSTOMER RECEIVED A BATTERY-OUT ALARM ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 150 MG/DL. THE CUSTOMER STATED THAT THEY HAD PUT A NEW BATTERY IN THE DEVICE AND THE PUMP WORKED AS DESIGNED. THE CUSTOMER STATED THEY SHOULD HAVE WAITED BEFORE THEY CALLED TO COMPLAIN ABOUT THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722368 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR