BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6018469 · Received October 11, 2016

    Report

    Report Number
    2032227-2016-29315
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE WS STUCK IN THE PRIMING PROCESS; THE CUSTOMER'S INSULIN PUMP BEGAN TO ALARM NO RESERVOIR WHILE HE WAS AWAY FROM THE DEVICE, AND WHEN HE RETURNED TWO HOURS LATER THE INSULIN PUMP PREVENTED HIM FROM COMPLETING THE PRIMING PROCESS. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. TROUBLESHOOTING WAS INITIATED FOR THE PRIMING ISSUE; HOWEVER, THE CUSTOMER RAN OUT OF INSULIN WHILE HE WAS BEING ASSISTED AND TROUBLESHOOTING COULD NOT BE COMPLETED. THE CUSTOMER STATED THAT HE WILL CALL BACK LATER. NO PRODUCTS WERE RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670654 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR