BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4811053 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61374
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    December 27, 2014
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING A BOLUS/BASAL DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS UNABLE TO PERFORM THE EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST DUE TO THE MOTOR ERROR ALARMS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE FILL CANNULA STEP WHEN THE CUSTOMER WAS IN THE PROCESS OF A SET CHANGE. THE CUSTOMER'S BLOOD GLUCOSE WAS 104 MG/DL. THE CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355855 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR