BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933499 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03837
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO TEST FOR ALARM DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP HAD MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY AND MOTOR.

    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 THE INSULIN PUMP ALARMED BUTTON ERROR AND AN UNEXPECTED RESTART TEST. CUSTOMER'S BLOOD GLUCOSE WAS 312 MG/DL. TROUBLE SHOOTING WAS PERFORMED. ALARMS WERE EXPLAINED TO CUSTOMER. UNEXPECTED RESTART TEST OCCURRED AFTER INSERTING A NEW BATTERY. CUSTOMER STATED THE DEVICE WAS STORED AND HADN'T BEEN IN USE FOR AN EXTENDED PERIOD TIME. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND TO REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410501 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR