BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LCAS PRDGM INS SK EN LN

    MDR report key: 1080472 · Received July 21, 2008

    Report

    Report Number
    2032227-2008-01269
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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'S MOTHER REPORTED THAT WHILE AT CAMP, THE CUSTOMER WAS TAKEN TO THE HOSPITAL DUE TO HYPERGLYCEMIA. THE CUSTOMER'S MOTHER WAS LEAVING FOR THE HOSPITAL AT THE TIME OF THE PHONE CALL, SO TROUBLESHOOTING COULD NOT BE PERFORMED. THE CUSTOMER'S MOTHER WAS ADVISED TO CALL BACK TO PERFORM TROUBLESHOOTING ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LCAS PRDGM INS SK EN LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization