BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3060915 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01384
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 30, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH CURRENTS IN SPECIFICATION. NO BATTERY OUT OF LIMIT. THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. NO FROZEN SCREEN. NO LOW RESERVOIR.

    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
    164083 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR