BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981340 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80292
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER REPORTED THAT THE ACT AND ESC BUTTONS WERE NOT RESPONDING AND THE TIME WAS NOT ADVANCING. THE CUSTOMER STATED THAT THE DISPLAY WAS NOT TOTALLY BLANK. TROUBLESHOOTING WAS PERFORMED. THE BATTERY WAS REMOVED FOR FIVE MINUTES AND THE INSULIN PUMP ALARMED. THE CUSTOMER STATED THAT SHE WAS NOT COMFORTABLE WITH THE DEVICE AND REQUESTED A REPLACEMENT OF THE INSULIN PUMP. ADVISED THE CUSTOMER TO 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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR