BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2942649 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-90809
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER EXPERIENCED NAUSEA, THIRSTY, AND DRIED MOUTH. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BASAL RATES WERE CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. THE CUSTOMER STATED THAT THE CANNULA WAS BENT WHEN SHE REMOVED IT SEVERAL WEEKS AGO, AND SHE WAS NOT WEARING THE DEVICE SINCE THEN. REMINDED THE CUSTOMER TO CHANGE THE INFUSION SET AND RESERVOIR EVERY TWO TO THREE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46886 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization