BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223431 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46993
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED BUTTON ERROR ALARM, DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE ON DISPLAY WINDOW CORNERS.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM FROM HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE CUSTOMER TREATED HER HIGH BLOOD GLUCOSE LEVEL WITH MANUAL INJECTIONS. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706823 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR