BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211993 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44978
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED FAILED BATTERY TEST ALARM WAS NOTED. NO UNEXPECTED NUMBER RAMPING ANOMALY WAS NOTED ON THE DISPLAY. THE INSULIN PUMP HAD INTERMITTENT DOWN ARROW BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, STAINED END CAP STICKER AND A STAINED ADDRESS AND SERIAL NUMBER LABEL.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER BUTTONS WERE UNRESPONSIVE WHILE SHE WAS ATTEMPTING A BOLUS. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THE NUMBERS WERE RAMPING UP ON HER INSULIN PUMP. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693804 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 22 YR