BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4850798 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-66105
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH AN INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCH ON THE ACT BUTTON AND UP ARROW BUTTON. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE NURSE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD TWO UNRESPONSIVE KEYS, THE ACT AND UP ARROW BUTTONS. THE CUSTOMER'S BLOOD GLUCOSE WAS 118 MG/DL. THE CALLER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CALLER STATED THAT THE BUTTONS DID RESPOND AT TIMES, BUT SHE HAD TO PRESS THEM VERY HARD TO GARNER A RESPONSE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CALLER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395164 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR