BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4000679 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-92888
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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

    IT WAS REPORTED THAT THE CUSTOMER NEEDED ASSISTANCE WITH PROGRAMMING HIS REPLACEMENT INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 475 MG/DL AND 5LL MG/DL AT THE END OF THE CALL. CUSTOMER TREATED HIS BLOOD GLUCOSE LEVEL MANUALLY WITH AN INJECTION. INSULIN PUMP WILL NOT BE RETURNED OR REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474699 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening