BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2142881 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-81891
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF OVER 600 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE LAST INFUSION SET CHANGE WAS THREE DAYS PRIOR TO HIS ADMISSION. THE TIME AND DATE ON THE INSULIN PUMP WAS NOT DISPLAYING AS THE BATTERY WAS DEAD. THE PROGRAMMING ON THE INSULIN WAS CORRECT. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL NO DELIVERY ALARMS. RAN A FIXED PRIME TEST AND THE INSULIN PUMP PASSED THE TEST. THE CUSTOMER STATED THAT THE CANNULAS HAVE BEEN BENT DOWNWARD. ADVISED THE CUSTOMER THAT THIS MAY HAVE BEEN WHAT WAS CAUSING THE NO DELIVERY ALARMS. 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-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization