BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123419 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29673
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 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
    KS
    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. PLEASE SEE MEDWATCH REPORT 2032227-2014-22248.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY MULTIPLE TIMES. THE CUSTOMER STATED THAT EVERY TIME THE ALARM OCCURRED, THEY CHANGED THE INFUSION SET HOSE AND THE ALARM CLEAR. THEY STATED THAT THEY HAD TO CHANGE THE HOSE EVERY OTHER DAY BECAUSE THEY WERE GETTING PUNCHED. THE CUSTOMER HAD REVERTED TO AN OLD INSULIN PUMP THAT THEY HAD, BUT THEY WERE ADVISED TO DISCONTINUE THE USE OF THAT DEVICE BECAUSE THEY HAD REPORTED A MOTOR ERROR ON THAT DEVICE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599969 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR