BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150016 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34807
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND THE OFF NO POWER ALARM FUNCTIONED PROPERLY. NO BLANK DISPLAY ANOMALY WAS NOTED. NO DAMAGE WAS FOUND ON THE ISOLATION TAPE. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND THE OFF NO POWER ALARM FUNCTIONED PROPERLY. NO BLANK DISPLAY ANOMALY WAS NOTED. NO DAMAGE WAS FOUND ON THE ISOLATION TAPE. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE CHANGED OUT HER BATTERY AND NOW HER INSULIN PUMP HAS A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE IS 215 MG/DL. SHE STATED THE ISSUE STARTED A WEEK AGO. SHE CHANGED HER BATTERY THREE TIMES AND SHE WAS ABLE TO DELIVER INSULIN, BUT TWO TO THREE HOURS LATER THE SCREEN WENT BLANK. REPLACING THE BATTERIES DOES NOT RESOLVE THE ISSUE. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626814 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 22 YR