BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4791166 · Received May 22, 2015

    Report

    Report Number
    2032227-2015-16514
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 13, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH NO ESC, UP AND DOWN BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS ON THEIR OWN OR SCROLLING BAR MOVING ANOMALY NOTED. THE INSULIN PUMP WAS UNABLE TO VERIFY ALARMS DUE TO NO ESC BUTTON RESPONSE. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW THRU RESERVOIR TUBE.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD BEEN OFF HER INSULIN PUMP FOR 2 DAYS DUE TO MOVING. CUSTOMER INSERTED A NEW BATTERY IN THE MORNING AND RECEIVED AN UNEXPECTED RESTART ALARM. CUSTOMER WAS NOT ABLE TO GET PAST THE TIME/DATE MENU DUE TO KEYPAD ISSUES. CUSTOMER STATED THAT THE PUMP WAS STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER'S BLOOD GLUCOSE WAS 150-160 MG/DL. CUSTOMER STATED THAT THE BUTTONS ARE HARD TO PRESS AND THE KEYS ARE FLUSHED. WHEN THE CUSTOMER PRESSED THE ACT AND ESC BUTTONS, THE PUMP STARTED COUNTING DOWN AGAIN. 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
    335550 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR