BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213351 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43329
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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

    CUSTOMER REPORTED NO DELIVERY ALARMS DURING FILL CANNULA. SHE STATED, SHE HAD REWOUND THE INSULIN PUMP AND NOW THE ALARM OCCURS WHILE SHE IS HOLDING THE ACT BUTTON. THE CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. TROUBLESHOOTING FOUND THE CUSTOMER WAS ABLE TO COMPLETE A MANUAL PRIME WITHOUT A NO DELIVERY ALARM. CUSTOMER WAS ADVISED THE INSULIN PUMP WAS WORKING AS DESIGNED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680799 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR