BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5151799 · Received October 15, 2015

    Report

    Report Number
    2032227-2015-56889
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA HELPLINE SOLUTIONS TRACKER OF A SCREEN ANOMALY FROM THE INSULIN PUMP. THE CUSTOMER STATED THAT WHEN SCROLLING THROUGH THE MENU AND BLOUSING, IT IS HARD TO READ THE SCREEN. THE CUSTOMER STATED THAT THE PUMP HAS A CONTRAST FLAW. THE CUSTOMER STATED THAT HER INSULIN IS SETUP TO EVERY 2 DAYS TO MAKE SURE SHE HAS PLENTY OF INSULIN SINCE THEY ARE IN THE PROCESS OF REGULATING HER BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682151 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR