BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1992970 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80350
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 TO BE COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING INVOLVED IN AN ACCIDENT AND WAS HOSPITALIZED. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 36 MG/DL. THE CUSTOMER STATED THAT HE WAS TAKING OTHER MEDICATIONS FOR OTHER REASONS. THE CUSTOMER STATED THAT THE DOCTOR CHANGED HIS BASAL RATES, AND HE IS USING THE INSULIN PUMP AND ALSO TAKING MANUAL INJECTIONS. 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization