BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4061220 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16784
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    CUSTOMER REQUESTED HELP WITH PROGRAMMING THEIR INSULIN PUMP AND REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 434 MG/DL. CUSTOMER STATED THAT THIS HIGH BLOOD GLUCOSE LEVEL WAS DUE TO NOT TAKING ANY INSULIN AFTER HER DINNER. DURING A FOLLOW UP CALL, CUSTOMER REPORTED BEING HOSPITALIZED FOR A BROKEN ARM AND A BROKEN LEG. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539847 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP A3723LNAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR