BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2123358 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81725
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN SCREEN. AFTER THE INSULIN PUMP WAS RESET, THE INSULIN PUMP FUNCTIONED PROPERLY. WE WERE UNABLE TO VERIFY THE AUDIO ANOMALY DUE TO THE FROZEN SCREEN. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO FROZEN SCREEN OR AUDIO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP MADE A LOUD SCREECHING NOISE WHEN A BATTERY WAS INSERTED. THE DIABETES SPECIALIST STATED THAT THE DISPLAY DID NOT APPEAR AND THAT AFTER CHANGING THE BATTERY THREE TIMES, THE INSULIN PUMP CONTINUED TO MAKE THE SAME LOUD NOISE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR