BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223293 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46747
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A NO DELIVERY ALARM POSSIBLY DUE TO OCCLUSION. CUSTOMER'S BLOOD GLUCOSE WAS 331 MG/DL. CUSTOMER WAS ABLE TO CLEAR ALARM WITH A COMPLETE INFUSION SET CHANGE. CUSTOMER REQUESTED TO RETURN INFUSION SET AND RESERVOIR FOR ANALYSIS AS CUSTOMER IS NOT ABLE TO COMPLETE TROUBLESHOOTING. INFUSION SET AND RESERVOIR WILL BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706438 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR