BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4801251 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59781
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP HAS AN UNRESPONSIVE KEYPAD. CUSTOMER'S BLOOD GLUCOSE LEVELS RANGED FROM 30 TO 600 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. TROUBLESHOOTING WAS DONE. ADVISED DISCONTINUATION OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. PRODUCT IS BEING RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347189 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR