BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3813003 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84610
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 27, 2014
    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 FAMILY MEMBER OR FRIEND

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    MOSITURE DAMAGE TO THE KEYPAD TRACES NOTED DURING VISUAL INSPECTION. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. NO TIME CHANGE ANOMALY OR FROZEN SCREEN OBSERVED DURING TESTING. A SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS WERE ALSO NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP TURNED OFF AND THE BATTERY WAS REMOVED AND REINSERTED, BUT THE DISPLAY WAS BLANK. THEN THE CALLER CHANGED THE BATTERY AND THE DEVICE HAD AN ERROR ALARM. THE BLOOD GLUCOSE READING WAS 310MG/DL. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL DIFFERENT ALARMS AND THE TIME CLOCK WAS FROZEN. FURTHER TESTING COULD NOT BE PERFORMED BECAUSE THE BUTTONS WERE UNRESPONSIVE. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291190 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR