BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212461 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43298
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S HAD MOTOR ERROR ALARM ON INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE TROUBLE SHOOTING WAS PERFORMED. THE CUSTOMER'S WAS TREATED WITH THE INSULIN PUMP. THE CUSTOMER'S WAS ADVISED TO DISCONNECT TO THE INSULIN PUMP AND RETRIEVE THEIR PUMP SETTINGS. THE PATIENT'S WAS ADVISED TO RETURNED THE BATTERY AND ZERO OUT THE BASAL RATES AND REVERT TO BACKUP PLAN. THE CUSTOMER'S WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680684 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening