BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141816 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33581
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A LOW BATTERY ALARM AND A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER DOES NOT DO DAILY SET REWINDS. PUMP IS IN VIBRATE MODE AND CUSTOMER DOES NOT UPLOAD FREQUENTLY. CUSTOMER WAS ADVISED THAT HE WOULD BE SHIPPED A REPLACEMENT BATTERY CAP. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. CUSTOMER STATED THAT HE HAD TO CHANGE BATTERIES MORE FREQUENTLY. CUSTOMER WAS ASSISTED IN PERFORMING A 5.0U FIXED PRIME AND INSULIN DID EXIT. IT WAS EXPLAINED THAT THERE MAY BE A POSSIBLE SITE RELATED ISSUE, POSSIBLY DUE TO A BENT CANNULA OR SITE/SET OCCLUSION. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET. CUSTOMER CHANGED HIS SET AND IT FIXED THE ISSUE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621790 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR