BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860731 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67759
    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
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST AND BUTTON ERROR. THE CUSTOMER STATED THAT THE INSULIN PUMP SHOWED AN ERROR INDICATING THAT THE INSULIN PUMP'S BUTTONS HAD BEEN PRESSED FOR MORE THAN 3 MINUTES. HE STATED THAT HE HAD BEEN SWIMMING IN THE OCEAN AND HAD DISCONNECTED FROM THE INSULIN PUMP, BUT WHEN HE RECONNECTED, HE NOTICED THE ERRORS. THE CUSTOMER DID NOT KNOW THE BLOOD GLUCOSE READING. HE STATED THAT THE BATTERY CAP CONTACTS WERE DAMAGED. HE STATED THAT THE METAL INSIDE OF THE BATTERY CAP HAD BEEN COMING OUT AND STICKING TO THE BATTERY. HE WAS ADVISED THAT A REPLACEMENT BATTERY CAP WOULD BE SENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN DUE TO THE BUTTON ERROR ALARM. THE CALLER WAS ADVISED TO REPLACE THE INSULIN PUMP AND A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR ANALYSIS. HE STATED THAT HE WOULD CALL BACK TO PROCESS THE REPLACEMENT WHEN HE RETURNED TO THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403962 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR