BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193633 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41328
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER'S MOTHER STATED THAT THEY ALSO RECEIVED A MOTOR ERROR ALARM AND THAT THE ALARM WAS CLEARED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 335 MG/DL. CUSTOMER CHECKED THE DATE AND IT SEEMED TO WORK. CUSTOMER WENT TO BOLUS AND HIS BLOOD GLUCOSE LEVEL WAS STARTING TO CLIMB AGAIN. TROUBLESHOOTING WAS OFFERED BUT THE CUSTOMER'S MOTHER DECLINED. CUSTOMER'S MOTHER STATED THAT SHE CHANGED OUT EVERYTHING EXCEPT THE RESERVOIR AND THE INSULIN. CUSTOMER'S MOTHER STATED THAT SHE IS GOING TO CHANGE OUT THE RESERVOIR AND ATTEMPT TO DELIVER AGAIN. CUSTOMER'S MOTHER WILL CALL BACK IF AN ALARM RECURS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672594 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR