BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183577 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40340
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 17, 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

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED MULTIPLE NO DELIVERY ALARMS FROM THE INSULIN PUMP WHILE TRYING TO BOLUS. TROUBLESHOOTING WAS DONE. THE CUSTOMER REPORTED A BENT CANNULA ON THE INFUSION SET. THE CUSTOMER ALSO REPORTED SCARRED AND HARDENED TISSUE OR STRETCH MARKS IN THE INFUSION AREA. THE CUSTOMER WAS ADVISED THAT THE NO DELIVERY ALARM MAY HAVE BEEN DUE TO THE BENT CANNULA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664052 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR