BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    MDR report key: 1932900 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83445
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 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 KETONES AND HIGH BLOOD GLUCOSE OF 192MG/DL. IT WAS STATED THAT THE INFUSION SET WAS CHANGED THREE DAYS PRIOR TO THE ADMISSION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization