BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1951854 · Received December 28, 2010

    Report

    Report Number
    2032227-2010-83587
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 586MG/DL. IT WAS STATED THAT THE CUSTOMER WAS THROWING UP AND DEHYDRATED. IT WAS STATED THAT THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE DAYS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SOMETIMES HE NOTICES RED OR SWOLLEN SITES. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization