BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183191 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39930
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER REPORTED THAT THE INSULIN PUMP MAY NOT HAVE BEEN FUNCTIONING PROPERLY. CUSTOMER REPORTED HAVING ERRATIC BLOOD GLUCOSE READINGS. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. BLOOD GLUCOSE LEVEL WAS 46 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED EXPERIENCING LOW BLOOD GLUCOSE LEVELS OVER THE WEEK LEADING UP TO THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661015 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR