BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103558 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26423
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE BOLUS PROCEDURE. THE BLOOD GLUCOSE READING WAS 408 MG/DL. THE CUSTOMER'S FATHER STATED THAT THIS WAS THE FOURTH INSULIN PUMP HE HAD RECEIVED THAT WAS ALARMING NO DELIVERY. HE STATED THAT THE ISSUE WAS RESOLVED BY A COMPLETE INFUSION SET CHANGE. THE CUSTOMER'S FATHER DECLINED RETURNING THE INFUSION SET AND RESERVOIR FOR ANALYSIS. HE WAS UNABLE TO TROUBLESHOOT BECAUSE HE WAS AWAY FROM THE CUSTOMER AND THE INSULIN PUMP. ADVISED THE CUSTOMER TO PERFORM A COMPLETE INFUSION SET CHANGE AS SOON AS POSSIBLE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584321 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR