BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4251722 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52628
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    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 RECEIVED A NO DELIVERY ALARM WITH A PREVIOUS RESERVOIR. CUSTOMER TOOK IT OUT AND PUT IN ANOTHER ONE AND IT WORKED, BUT THE INSULIN CAME OUT REALLY FAST. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 92 MG/DL, WHICH IS REALLY LOW FOR HER. CUSTOMER THINKS SHE IS POSSIBLY GETTING TOO MUCH INSULIN. CUSTOMER REPORTED THAT THE ALARM WAS RESOLVED BY A RESERVOIR CHANGE. CUSTOMER DOES NOT WANT TO RETURN THE SET OR RESERVOIR FOR ANALYSIS. CUSTOMER STATED THAT THE ALARM OCCURRED DURING MANUAL PRIME. CUSTOMER WAS NOT ABLE TO TROUBLESHOOT AT THE TIME OF THE CALL. THE CAUSE OF THE ISSUE WAS NOT ABLE TO BE DETERMINED. RESERVOIR WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735981 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR