BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION

    MDR report key: 2842651 · Received November 21, 2012

    Report

    Report Number
    2032227-2012-07806
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. 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

    UNRESPONSIVE BUTTONS DUE TO MOISTURE DAMAGE ON KEYPAD TRACE. DISPLAY FUNCTIONS PROPERLY WITH TESTING CASE. NO FROZEN DISPLAY NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY. CUSTOMER STATED THAT THE TIME ON THE INSULIN PUMP IS NOT ADVANCING AND THERE IS NO RESPONSE FROM ANY BUTTON. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION OYC OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR