BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4203364 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43581
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 210 MG/DL. THE CUSTOMER REPORTED THAT THE BATTERY OF THE INSULIN PUMP WOULD NOT LAST LONG. IT WAS REPORTED THAT THE CUSTOMER WAS USING A NEW BATTERY CAP THAT WAS PREVIOUSLY SHIPPED. THE CUSTOMER ALSO REPORTED A FAILED BATTERY TEST ON THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A WEAK BATTERY ALARM FROM THE INSULIN PUMP. THE CUSTOMER FURTHER REPORTED LOW BATTERY ALARM FROM THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. IT WAS REPORTED THAT THE CUSTOMER WAS USING A FRESH BATTERY BUT WOULD STILL RECEIVE THE ABOVEMENTIONED ALARMS ON THE INSULIN PUMP. IT WAS REPORTED THAT THE CUSTOMER WAS NOT USING THE SENSOR FEATURE ON THE INSULIN PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683935 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR