BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4433449 · Received January 20, 2015

    Report

    Report Number
    3004209178-2015-85570
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    December 31, 2014
    Report Date
    January 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    IT WAS REPORTED THAT CUSTOMER IS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. IT WAS ALSO REPORTED THAT THERE ARE AIR BUBBLES IN THE RESERVOIR OF THE INSULIN PUMP. CUSTOMER ADDED THAT THE PUMP HAS BENT CANNULAS AS WELL. CUSTOMER'S BLOOD GLUCOSE READING RANGED FROM 253-290 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44787 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR