BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4854857 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-66598
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 30, 2015
    Report Date
    May 30, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS OF 400 MG/DL, BUT QUICKLY DROPPED TO 32 MG/DL AFTER USING INSULIN SHOTS. THE ALARM OCCURRED AFTER A BATTERY CHANGE. THE CUSTOMER CLEARED THE ALARM AND WAS ASSISTED WITH PROGRAMING THE DATE AND TIME IN THE INSULIN PUMP. THE CUSTOMER WAS INFORMED THAT THE ALARM IS A NORMAL INSULIN PUMP FUNCTION. THE CUSTOMER NOTICED THAT THE BATTERIES SEEM TO BE DRAINING QUICKLY. THE CUSTOMER WAS ADVISED TO CALL BACK IF THE ISSUE WERE TO OCCUR AGAIN SO THAT THE INCIDENT CAN BE DOCUMENTED. THE CUSTOMER DID NOT RETURN THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396367 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other