BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193030 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41775
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD UNRESPONSIVE BUTTONS ON THE INSULIN PUMP. CUSTOMER STATED THAT NONE OF THE BUTTONS ARE WORKING, EXCEPT THE DOWN ARROW BUTTON. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER CALLED BACK LATER AND STATED THAT THE PUMP SEEMS TO WORK NOW. CUSTOMER WANTED TO KNOW IF THE BASAL IS STILL BEING DELIVERED. CUSTOMER WAS ADVISED AGAIN TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. CUSTOMER WAS ALSO ADVISED TO MONITOR HIS BLOOD GLUCOSE LEVEL CLOSELY. CUSTOMER WAS ADVISED THAT EITHER A NO DELIVERY OR ANY OTHER ALARMS WITH CLOSED CIRCLES WILL INDICATE THE STOP OF DELIVERY. CUSTOMER CALLED BACK AGAIN AT A LATER DATE AND STATED THAT THE REPLACEMENT PUMP ALSO HAD A BUTTON ALARM. CUSTOMER WAS ADVISED THAT A LETTER WILL BE SENT STATED THAT MEDTRONIC RECEIVED THE PUMP BACK. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671478 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR