BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150322 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34962
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED THAT HE RECEIVED A NO DELIVERY ALARM DURING A SET CHANGE. THE CUSTOMER ATTEMPTED TO USE NEW TUBING AND A PRE-FILLED RESERVOIR, BUT WAS UNABLE TO MANUALLY PRIME PAST 5.0 UNITS WITHOUT A NO DELIVERY ALARM. HE COULD NOT COMPLETE TROUBLESHOOTING AS NOT ALL SUPPLIES WERE AVAILABLE. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN AND CHANGE OUT THE SET COMPLETELY AS SOON AS POSSIBLE. HIS BLOOD GLUCOSE WAS 286 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628651 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR