BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183116 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40140
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 HAD KEYTONES. IT WAS ALSO REPORTED THAT THE CUSTOMER'S INSULIN PUMP RECEIVED AN AUTO OFF ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 311MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP IS GOING INTO SUSPEND IN THE MIDDLE OF THE NIGHT. TROUBLESHOOTING OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661163 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR