BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090171 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81380
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 1, 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
    OTHER

    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 FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 718MG/DL. THE CUSTOMER STATED THAT SHE POSSIBLY INJECTED IN AN AREA THAT HAS SCAR TISSUE. THE CUSTOMER STATED THAT HER HIGH GLUCOSE WAS TREATED WITH INSULIN DRIP WHILE STAYING IN THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND SETTINGS ON THE INSULIN PUMP. RAN A FIXED AND HIGH PRESSURE TEST AND THE DEVICE PASSED THE TESTS. NO FURTHER INFO 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 57 YR Hospitalization