BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4761219 · Received May 9, 2015

    Report

    Report Number
    3004209178-2015-54341
    Event Type
    Injury
    Date Received
    May 9, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 430 MG/DL. THE CUSTOMER STATED THAT THEY SIMPLY DID NOT FEEL WELL AND HAS BEEN SWEATING AND SKIN IRRITATION FROM CLOTHING RUBBING AGAINST THE INFUSION SET. THE CUSTOMER STATED THAT THEIR INSULIN USAGE HAS DOUBLED SINCE EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH REVIEWING THEIR SETTINGS. AFTER REVIEWING THE SETTINGS ON THE PUMP IT APPEARED THAT THERE WAS NOTHING WRONG WITH THEIR INSULIN PUMP. THE DEVICE WILL NOT BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305837 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR