BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2091434 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81389
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 WAS REPORTED THAT THE INSULIN PUMP'S DISPLAY WAS FROZEN WHILE THE CUSTOMER WAS DELIVERING INSULIN. TROUBLESHOOTING WAS PERFORMED. ADVISED THE CUSTOMER TO REMOVE THE BATTERY FOR 10 MINUTES. THE CUSTOMER STATED THAT AFTER LETTING THE INSULIN PUMP REST THE DISPLAY CAME BACK. REVIEWED THE BOLUS HISTORY AND FOUND THAT THERE WAS A BOLUS STOP ALARM. NO FURTHER INFO 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 58 YR