BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4761312 · Received May 9, 2015

    Report

    Report Number
    3004209178-2015-54693
    Event Type
    Injury
    Date Received
    May 9, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 OF 487MG/DL. THE CUSTOMER STATED THAT THEY NEED TO GET OFF THE PHONE TO MANUALLY TREAT THEMSELVES AND WILL CALL BACK TO TROUBLESHOOT THE ISSUE. THE CUSTOMER STATED THEY WILL MONITOR THEIR BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305912 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR