BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981352 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06107
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. UNABLE TO VERIFY UNEXPECTED BATTERY OUT OF LIMIT ALARMS DUE TO UNRESPONSIVE BUTTONS. THE DEVICE ALSO WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND RESERVOIR TUBE, MINOR SCRATCHED LCD WINDOW.

    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 HIS INSULIN PUMP ALARMED BUTTON ERROR. HIS BLOOD GLUCOSE IS 250 MG/DL. CUSTOMER STATED HE WAS DOING A COMPLETE SET CHANGE AND DURING THE FILL TUBING PROCESS, THE DEVICE STARTED TO PRIME ON ITS OWN. HE STARTED PRESSING BUTTONS TO STOP THE DEVICE AND IT STOPPED. THE DEVICE THEN ALARMED BATTERY ERROR. AFTER PUTTING IN A NEW BATTERY, THE DEVICE ALARMED BUTTON ERROR. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457973 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR