BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2020475 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80437
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 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
    SW
    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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER NOTICED ON HER CARELINK PERSONAL REPORTS SOME TEMPORARY BASALS PROGRAMMED, WHICH THE CUSTOMER DID NOT PROGRAM. IT WAS STATED THAT AFTER REVIEWING THE REPORTS, THERE WERE SEVERAL INCIDENTS FROM (B)(6), 2010 THRU (B)(6), 2011, AND A BIG INCREASE OF TEMPORARY BASALS WERE RECORDED, THAT THE CUSTOMER DID NOT RECOGNIZE. IT WAS STATED THAT MOST OF THE BASAL PROGRAMMED OCCURRED IN THE EVENING. IT WAS ALSO STATED THAT ON (B)(6), 2011 THE TEMPORARY BASAL HAS BEEN PROGRAMMED FOUR TIMES WITHOUT THE CUSTOMER'S INTERVENTION. 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-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1