BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1992958 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80348
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 TO BE COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING DIFFICULTIES DOWNLOADING THE INSULIN PUMP INTO THE CARELINK. IT WAS STATED THAT THE DEVICE ALARMED AND ALL THE ENTRIES WERE DISCARDED. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL ERROR ALARMS. IT WAS STATED THAT THE DEVICE HAD RECURRING NO DELIVERY ALARMS AND LOW BLOOD GLUCOSE. IT WAS STATED THAT THE PARAMEDICS WERE CALLED, BUT THE CUSTOMER WAS NOT ABLE TO RECALL MORE DETAILS. ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION, BUT THE CONTACT ENDED THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization