BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183579 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40341
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    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

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED THAT INSULIN WAS SQUIRTING OUT OF THE INSULIN PUMP DURING THE PRIMING PROCESS. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS ADVISED THAT LIQUID ON THE INSIDE OF THE TUBING CONNECTOR CAN TEMPORARILY BLOCK THE VENTS THAT ALLOW PROPER PRIMING. THE CUSTOMER ALSO REPORTED A COMPROMISED FORCE SENSOR SYSTEM ERROR BASED ON THE ALARM HISTORY FROM THE INSULIN PUMP. THE CUSTOMER REPORTED THAT AN INFUSION SET CHANGE RESOLVED THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663964 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR