BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192817 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95119
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTION PROPERLY. HOWEVER, MOISTURE DAMAGE FOUND ON KEYPAD TRACES. NO FROZEN DISPLAY NOTED. NO SCROLL BAR MOVING WITH NO INPUT NOTED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER, (B)(6) CALLED TO REPORT FROZEN DISPLAY. PRESSED THE ACT BUTTON AND THE SCREEN DID NOT MOVE. THE ESC BUTTON DID NOT RESPOND. THE CUSTOMER'S BLOOD GLUCOSE READING IS 312 MG/DL. TREATED WITH MANUAL INJECTION. THE SCREEN IS NOT BLANK AND THE TIME DID NOT ADVANCE. ADVISED CALLER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291657 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR