BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5171701 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-58743
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED THE DISPLACEMENT, MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO LOOSE OR FLUSH DRIVE SUPPORT DISK. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING A BOLUS. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ERROR. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS DONE FOR MOTOR ERROR AND FOUND THAT THERE WERE ALARMS IN PUMP HISTORY. THE CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE BUT THE PUMP ALARMED AGAIN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701010 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR