BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242765 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50260
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 HAD A PHYSICAL DAMAGED ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 320 MG/DL. THE CUSTOMER TREATED HERSELF WITH EXTRA BOLUS AND TOOK A PILL MACFORMEN 1000 MG. THE CUSTOMER STATED THAT THEIR IS STRIPPED AT TOP OF THE BATTERY COMPARTMENT. THE CUSTOMER ALSO STATED THAT SHE COULD NOT REMOVED THE BATTERY CAP. THE CUSTOMER WAS ADVISED TO MONITOR IF THEY CONTINUE THE USE OF INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP IF THE BATTERY IS LOW. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEED TO BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725513 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR