BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2002484 · Received February 16, 2011

    Report

    Report Number
    2032227-2011-00441
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THE CUSTOMER REPORTED CALLING THE PARAMEDICS ON TWO OCCASIONS. ONCE LAST WEEK, AND AGAIN THIS MORNING DUE TO LOW BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 443 MG/DL. THE CUSTOMER TREATED HERSELF WITH AN INJECTION, AND BEGAN TO FEEL BETTER. TROUBLESHOOTING WAS PERFORMED, AND THE TIME WAS OFF BY AN HOUR. ALL OTHER PROGRAMMING WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME TEST. FOUND TWO BOLUSES IN THE BOLUS HISTORY THAT THE CUSTOMER DIDN'T RECALL PROGRAMMING. THE CUSTOMER FELT THAT SHE NEEDED ADDITIONAL TRAINING. ADVISED THAT THE LOCAL REPRESENTATIVE WOULD BE NOTIFIED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention