BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860734 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67763
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 31, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 INTERMITTENT BUTTON RESPONDS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED DURING TESTING. THE FOLLOWING COSMETIC DAMAGE WAS NOTED ON THE DEVICE: CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR DURING A BOLUS ATTEMPT. THE CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE ALARM OR KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CALLER ADVISED THAT THE CUSTOMER HAD ALREADY REVERTED TO A BACK-UP PLAN. THE CUSTOMER 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
    403963 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR