BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183505 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40242
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 CHANGED HER BATTERY 3 TIMES AND SHE GOT A BLACK SCREEN ON THE PUMP. CUSTOMER'S PUMP WAS ALARMING AND WHEN SHE CHANGED THE BATTERY, HER SCREEN WENT ALL BLACK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 380 MG/DL. CUSTOMER GAVE 3 UNITS WITH HER DIAL DOSE PEN. CUSTOMER STATED THAT THE PUMP ALARMED AFTER THE BATTERY CHANGE. CUSTOMER STOPPED USING THE PUMP BECAUSE THERE WAS BLOOD ON HER SET. PUMP WAS ALARMING AT THE TIME OF THE CALL. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER HAD RECEIVED MULTIPLE BATT OUT LIMIT ALARMS WHEN BATTERIES WERE OUT OF THE PUMP FOR LESS THAN ONE MINUTE. BATT OUT LIMIT ALARM OCCURRED BECAUSE THE CUSTOMER NEVER CLEARED IT. CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE PUMP STARTED WORKING SO IT WILL NOT NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663941 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR