BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132549 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31418
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. 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.(B)(4)

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE ON KEYPAD TRACES. ALL BUTTONS FUNCTION PROPERLY. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP. MOISTURE DAMAGE WAS FOUND ON ELECTRONIC AND MOTOR ASSEMBLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP'S ACT AND ESCAPE BUTTONS WERE NO LONGER RESPONDING. CUSTOMER REPORTED THAT SHE HAD RECENTLY JUMPED INTO A LAKE WHILE WEARING THE INSULIN PUMP. BLOOD GLUCOSE LEVEL WAS 256 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610394 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR