BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3173977 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94791
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 30, 2012
    Report Date
    June 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    INITIALLY, THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER DECLINED TO TROUBLESHOOT AS CUSTOMER DID NOT FEEL THE INSULIN PUMP WAS MALFUNCTIONING. THE CUSTOMER STATED THAT HER HIGH BLOOD GLUCOSE PERSISTED SINCE SHE CHANGED THE ENTIRE INFUSION SET AND RESERVOIR. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 496MG/DL. A FOLLOW UP WAS CONDUCTED AND FOUND THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE, AND SHE WAS TREATED AND RELEASED ONCE HER GLUCOSE LEVEL WENT DOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273811 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization