BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141806 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33589
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    IT IS REPORTED THAT A CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE PATIENT'S BLOOD GLUCOSE WAS NOT RECORDED. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS ADVISED TO CHANGE THE SET RESERVOIR. THE PATIENT WAS DIRECTED TO MONITOR THE PUMP FOR ANY FURTHER ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621779 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR