BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4192679 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41101
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. ALL BUTTONS RESPONDED PROPERLY. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT AND MINOR SCRATCHES ON LCD WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A LOW PREDICT ALARM AND THE ESC BUTTON WAS UNRESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP WAS IN THE BATHROOM WITH HER WHILE TAKING A SHOWER. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 88 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673328 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR