BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4053055 · Received September 2, 2014

    Report

    Report Number
    2032227-2014-15988
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE AND ALARMED FOR A BUTTON ERROR DUE TO CORRODED KEYPAD TRACES. NO NUMBER RAMPING ANOMALY WAS NOTED ON THE DISPLAY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NONE OF THE BUTTONS ON THE CUSTOMER'S INSULIN PUMP WERE WORKING, THEY WERE SCROLLING UP ON THEIR OWN, AND A BUTTON ERROR WAS RECEIVED. IT WAS ADVISED FOR THE CUSTOMER TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 197 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534590 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR