BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234000 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82774
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    July 2, 2011
    Report Date
    August 16, 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 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 HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 560 MG/DL. THE CUSTOMER DENIED TROUBLESHOOTING THE INSULIN PUMP. THE CUSTOMER STATED THAT THE CAUSE OF HIS ADMISSION WAS THE CANNULA BEING BENT. THE CUSTOMER STATED THAT HE HAS TREATED WITH A MEAL AND HE IS DOING FINE AT TIME OF CALL. 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-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization QUICK-SET 32" PARADIGM 9MM CATHETER| (B)(4) INFUSION SET, MMT-386