BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2243742 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82369
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 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 UNKNOWN WHETHER OR NOT THER 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NUMBERS ON THE INSULIN PUMP WERE RAMPING ON ITS OWN. IT WAS STATED THAT THE BUTTONS BECAME STUCK WHEN THE CUSTOMER WAS BOLUSING. THE BATTERY WAS CHANGED AND THEN THE INSULIN PUMP ALARMED BATTERY ERROR. IT WAS STATED THAT THE MOTHER ATTEMPTED TO INSERT A NEW BATTERY AND THE INSULIN PUMP DISPLAYED THE VERSION NUMBER. EXPLAINED THAT THE BUTTONS ARE UNRESPONSIVE AND THE SCREEN IS FROZEN. ADVISED TO HAVE THE CUSTOMER DISCONTINUE USING THE INSULIN PUMP. NO FURTHER INFORMATION 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1