BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4823726 · Received June 8, 2015

    Report

    Report Number
    3004209178-2015-63358
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING TESTING. THE DEVICE HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY OR FRIEND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR, WHICH COULD NOT BE CLEARED. THE CALLER STATED THAT THE INSULIN PUMP INDICATED THAT A BUTTON HAD BEEN PRESSED FOR 3 MINUTES, AND THE ESC AND ACT BUTTONS WERE UNABLE TO CLEAR THE NOTIFICATION. THE CUSTOMER'S BLOOD GLUCOSE WAS 147 OR 149 MG/DL. THE CALLER STATED THAT THE CUSTOMER WAS ON VACATION, WHERE THE CUSTOMER WAS SWEATING A LOT DUE TO HOT WEATHER. 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
    367832 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR