BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2871831 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-91355
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    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 IN TWO SEPARATE OCCASIONS DUE TO HIGH BLOOD GLUCOSE OVER 500MG/DL, AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP AND FLUIDS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY REPEATEDLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC CGA MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization