BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3954093 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04682
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S INSULIN PUMP STOPPED WORKING BECAUSE IT WENT THROUGH AN MRI. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 286 MG/DL. THE DEVICE ALARMED MOTOR ERROR DURING A BASAL DELIVERY. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVEN THAT MAY HAVE CAUSED THE ALARM. THE DEVICE DID GO THROUGH AN MRI. CUSTOMER DOES USE SENSOR FEATURE, INFORMED ABOUT POSSIBLE FALSE ALARM OCCURRENCE WHEN VIEWING REPORT WHEN BOLUS. CUSTOMER IS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. TRANSMITTER WAS ALSO WORN THROUGH THE MRI. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430277 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR