BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2070267 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-81110
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 TREATED BY PARAMEDICS FOR HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 35 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS PUT ON IN A CLASS AND THAT THE DIABETIC MANAGER TEACHING THE CLASS PROGRAMMED THE SETTINGS. THE CUSTOMER ALSO STATED THAT ONCE THE PARAMEDICS LEFT, HER BLOOD GLUCOSE LEVELS WERE STILL LOW, AND THAT SHE HAD TO SNACK TO ELEVATE HER BLOOD GLUCOSE LEVELS. THE CUSTOMER THEN STATED THAT SHE HAD KEPT THE INSULIN PUMP ON DURING TREATMENT AND THAT HER BASAL RATE HAS BEEN AT 3.75 UNITS PER HOUR. 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 PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention