BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120030 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-28527
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    July 3, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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 ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND IT PASSED. THE DEVICE PASSED SELF-TEST AND DISPLACEMENT TEST. NO EXTERNAL RAM CRC ERROR ALARMS NOTED DURING TESTING. THE DEVICE ALARMED UNEXPECTED RESTART AFTER BATTERY INSTALLATION DUE TO BROKEN SOLDER JOINT AT CONNECTOR ON THE INTERFACE BOARD. THE DEVICE HAD CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED DISPLAY WINDOW, AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MULTIPLE ERROR ALARMS, INCLUDING A MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE ALARMS KEPT OCCURRING TWICE A DAY, AND EVERY TIME THERE WAS A MOTOR ERROR, ANOTHER ERROR ALARM FOLLOWED. THE TIME OF THE INSULIN PUMP HAD BEEN RESET. THE ALARMS WERE CONFIRMED IN THE ALARM HISTORY OF THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596985 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR