BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183515 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40218
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED A NO DELIVERY ALARM DURING A MANUAL PRIME. THE MOTHER STATED HER SON'S BLOOD GLUCOSE WAS 445 MG/DL. THE CUSTOMER HAS REVERTED TO MANUAL INJECTIONS. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING. THE INSULIN PUMP ALARMED NO DELIVERY AGAIN DURING A MANUAL PRIME. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WAS WORKING AS DESIGNED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663944 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR