BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860730 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67757
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 3, 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 Location
    TX
    Reporter Occupation
    OTHER

    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

    NO UNEXPECTED BATTERY OUT LIMIT ALARMS NOTED DURING TESTING. THE INSULIN PUMP PASSED DISPLACEMENT TEST AND OFF NO POWER TEST. THE OPERATING CURRENTS WERE IN SPECIFICATIONS. THE INSULIN PUMP ALARMED BUTTON ERROR AFTER BOOT UP AND AN INTERMITTENT BUTTON RESPONSE ON THE ESC BUTTON DUE TO CORRODED KEYPAD TRACES NOTED. THE INSULIN PUMP HAD A CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT SHE NOW HAS A BATTERY OUT LIMIT ALARM. CUSTOMER TRIED TO RESET IT WITH A NEW BATTERY AND IT QUIT ALARMING. CUSTOMER HAD THE PUMP IN HER POCKET WHEN SHE RECEIVED THE BUTTON ERROR ALARM. CUSTOMER MENTIONED THAT SHE HAS NOT HAD INSULIN SINCE NOON. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404168 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 48 YR