BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141895 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33631
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP DISPLAY WAS GOING BLANK, OFF AND ON. THE PATIENT'S BLOOD GLUCOSE WAS 347 MG/DL, WHICH WAS TREATED WITH THE INSULIN PUMP. THERE WERE NO SIGNS OF PHYSICAL DAMAGE AND THE INSULIN PUMP WAS STATED NOT TO HAVE BEEN DROPPED, BUMPED OR EXPOSED TO MOISTURE. IT WAS STATED THAT THE PATIENT'S BLOOD GLUCOSE WAS 570 MG/DL AT THE FIRST OCCURRENCE OF THE ISSUE, BECAUSE SHE DID NOT KNOW HOW LONG THE INSULIN PUMP HAD BEEN OFF. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621498 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR