BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2091360 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81356
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CRACKS NEAR THE LIQUID CRYSTAL DISPLAY. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE CHANGES THE BATTERY AND THE BUTTONS STILL WERE UNRESPONSIVE. THE CUSTOMER STATED THAT THE TIME ON THE INSULIN PUMP WAS NOT ADVANCING AND THE DISPLAY WAS FROZEN. ALSO, THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED AND THE ALARM WAS NOT ABLE TO BE CLEARED. 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 32 YR