BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2193327 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-82286
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 346MG/DL. IT WAS STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING A BOLUS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER HAD INSERTED THE INFUSION SET IN HER LEG. IT WAS STATED THAT THE CUSTOMER'S ALTERNATES BETWEEN THE LEG AND THE ABDOMEN. RAN A FIXED PRIME TEST AND PASSED. ADVISED THE DOCTOR THAT UNTIL THE CUSTOMER CHANGES THE INFUSION SET AND RESERVOIR THE CUSTOMER SHOULD ATTEMPT TO TREAT WITH A BACK UP PLAN. 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 27 YR Hospitalization