BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132490 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31706
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 HER INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER'S BLOOD GLUCOSE WAS 70 MG/DL. THE CUSTOMER STATED SHE HAD FALLEN OFF THE DOCK WITH HER BATHING SUIT ON. SHE STATED THERE WAS NOW MOISTURE OR CONDENSATION ON THE TOP LEFT OF HER DISPLAY. IT WAS ALSO FOUND THE INSULIN PUMP PASSED THE SELF TEST. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611928 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR