BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2243550 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82824
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 ADMITTED AT THE INTENSIVE CARE UNIT DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE INFUSION SET WAS NOT CHANGED PRIOR TO GOING TO THE HOSPITAL AND THE CANNULA WAS BENT. 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 CO., JUNCOS MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization MMT-397| PARADIGM 9MM CATHETER| (B)(4) INFUSION SET| QUICK SET 23