BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4771053 · Received May 14, 2015

    Report

    Report Number
    2032227-2015-15662
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    June 7, 1949
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE UNABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER STATED THE ISSUE OCCURRED TOWARDS THE END OF INSERTING THEIR RESERVOIR. CUSTOMER'S BLOOD GLUCOSE WAS 285 MG/DL. THE CUSTOMER ALSO REPORTED AN OPEN CIRCLE ON THEIR INSULIN PUMP. CUSTOMER WAS ASSISTED WITH TURNING OFF THE BLOCK FEATURE ON THE INSULIN PUMP. CUSTOMER WAS ABLE TO REWIND SUCCESSFULLY AT THE END OF THE CALL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315384 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA