BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4130065 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24514
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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. THE DEVICE HA BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER TRIED PROGRAMMING INFORMATION INTO THE INSULIN PUMP, THE NUMBERS KEPT SCROLLING UP NONSTOP. ALSO, THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. THE CUSTOMER STATED THAT THE REPORTED EVENT HAPPENED ONE MONTH PRIOR TO THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579695 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR