BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232619 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82198
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD A FROZEN DISPLAY. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 419 MG/DL AND WAS TREATED WITH INSULIN PEN. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE BUTTONS WERE UNRESPONSIVE. THE BATTERY WAS CHANGED, THE BUTTONS STILL DID NOT RESPOND AND THE TIME ON THE INSULIN PUMP WAS NOT ADVANCING. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR