BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170108 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37725
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 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

    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 CUSTOMER HAD A MOTOR ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 261 MG/DL. CUSTOMER WENT TO CHANGE OUT THE RESERVOIR AND IT WAS NOT SHOWING ON THE PUMP. CUSTOMER STATED THERE WAS A CIRCLE AND THE BATTERY WAS LOW. CUSTOMER CHANGED IT OUT AND NOW IT IS SHOWING THE WRONG TIME AND THE MOTOR ERROR ALARM OCCURRED. CUSTOMER STATED THAT THE ALARM OCCURRED AFTER DOING A BOLUS AND THERE ARE SCRATCHES ON THE PUMP. CUSTOMER WAS NOT SURE IF HE DROPPED IT OR NOT. IF IT WAS DROPPED, IT WAS NOT DROPPED VERY HARD. CUSTOMER JUST DANGLED THE PUMP AND WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER DECLINED TROUBLESHOOTING FOR THE ISSUES. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649524 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR