BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2123163 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81756
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2011-01435.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS IN THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVELS, GASTROPARESIS AND HYPERTENSION. THE CUSTOMER WAS VOMITING AS WELL. THE CUSTOMER ALSO STATED THAT SHE WORE THE SENSOR DURING AN MRI SCAN, BUT WASN'T SURE IF SHE WAS WEARING THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME, DISPLACEMENT AND HIGH PRESSURE TESTS. 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-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization