BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4191274 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41552
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 BELIEVED THAT HIS INSULIN PUMP WAS NOT DISPLAYING THE PROPER AMOUNT OF INSULIN. HIS BLOOD GLUCOSE AT THE TIME OF REPORTING WAS 217MG/DL. HE STATED THAT HIS BOLUS HISTORY SHOWS LOWER DOSES BEING ADMINISTERED THAN THOSE HE SET. TROUBLESHOOTING SHOWED THAT MOST OF THE INACCURACIES CORRESPONDED TO NO DELIVERY ALARMS AT THE TIME OF BOLUS. THE CUSTOMER WILL CONTINUE MONITORING HIS INSULIN PUMP AND CALL BACK IF THE PROBLEM PERSISTS AND FURTHER TROUBLESHOOTING IS REQUIRED. NO EQUIPMENT IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669478 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR