BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2151499 · Received June 24, 2011

    Report

    Report Number
    3004209178-2011-81969
    Date Received
    June 24, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST WEEK. IT WAS STATED THAT THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 325 MG/DL, AND THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME TEST AND THE TEST PASSED. IT WAS STATED THAT THE CUSTOMER HAD BENT CANNULAS. 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-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization QUICK-SET PARADIGM 43", 9MM| UNOMEDICAL INFUSION SET: MMT-396