BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4790892 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58508
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO CORRODED ELECTRONIC ASSEMBLY. THE INSULIN PUMP WAS UNABLE TO VERIFY FAILED BATTERY TEST ALARM OR UNRESPONSIVE KEYPAD/BUTTONS DUE TO BLANK DISPLAY. THE INSULIN PUMP HAD MOISTURE DAMAGE ON MOTOR. NO MOISTURE DAMAGE ON KEYPAD TRACES NOTED. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST AND EXPERIENCED KEYPAD ISSUES. THE CUSTOMER WAS UNABLE TO BOLUS. THE CUSTOMER'S WIFE STATED THAT THE ARROW KEY BUTTONS WERE NOT WORKING PROPERLY. THE CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL. WHILE TROUBLESHOOTING, THE CUSTOMER WAS ADVISED THAT IF THE FAILED BATTERY TEST ALARM WAS NOT CLEARED THEN IT WOULD RECUR WITH EACH NEW BATTERY INSERTED. IT WAS FOUND THAT NEITHER THE BATTERY COMPARTMENT NOR SPRING WERE DAMAGED OR CORRODED. THE CUSTOMER DID NOT RECEIVE ANOTHER FAILED BATTERY TEST ALARM. THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WAS INFORMED THE DEVICE WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333859 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR