BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT - 722LNAB

    MDR report key: 1962816 · Received January 11, 2011

    Report

    Report Number
    2032227-2011-00104
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT SHE CANNOT HEAR THE INSULIN PUMP WHEN IT ALARMS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE SELF TEST. THE CUSTOMER LATER CALLED AND STATED THAT SHE NO LONGER WANTED TO USE THE INSULIN PUMP DUE TO BEING HOSPITALIZED. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ABOUT THE HOSPITALIZATION. THE TERRITORY MANAGER WAS NOTIFIED ABOUT THE SITUATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT - 722LNAB INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization