BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2202418 · Received August 4, 2011

    Report

    Report Number
    3004209178-2011-82420
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED ON LATE JUNE FOR FOUR DAYS DUE TO HIGH BLOOD GLUCOSE OF OVER 600MG/DL. THE CUSTOMER STATED THAT SHE WAS TOLD AT THE HOSPITAL THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY AND CAUSED HER BLOOD GLUCOSE TO RISE. THE CUSTOMER STATED THAT SHE HAS NOT USED THE INSULIN PUMP IN ALMOST TWO MONTHS, AND SHE IS NOT COMFORTABLE WITH IT. OFFERED A REPLACEMENT OF THE INSULIN PUMP AND SHE DECLINED. 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-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization