BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894870 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03376
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF ABOVE 400 MG/DL. THE CUSTOMER HAD CHEST PAINS. THE CUSTOMER STATED THAT THEY DO NOT USE THE BOLUS WIZARD SETTING ON THE INSULIN PUMP; INSTEAD THEY GUESS THE AMOUNT OF THE INSULIN THAT NEEDS TO BE DELIVERED FOR FOOD INTAKE. THE HOSPITAL TREATED THE CUSTOMER WITH INSULIN DRIPS. THE CALLER RAN A PRIME TEST AND INSULIN EXITED THE TUBING. THE HIGH PRESSURE TEST AND THE SELF TEST ALSO PASSED. IN THE ALARM HISTORY OF THE INSULIN PUMP THERE WERE SEVERAL NO DELIVERY ALERTS FOUND. EXPLAINED TO THE CALLER THAT THE INSULIN PUMP IS FUNCTIONING AS DESIGNED AND DOES NOT NEED TO BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369872 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization