BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1211722 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01834
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    February 26, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED SEVERAL TIMES, DUE TO HYPERGLYCEMIA. THE CUSTOMER'S DOCTOR REPORTED THAT GOING THROUGH PUBERTY MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ERRATIC BLOOD GLUCOSE LEVELS. THE CUSTOMER'S MOTHER STATED THAT THEY ARE CURRENTLY WORKING WITH THE CUSTOMER'S DOCTOR TO ADJUST THE SETTINGS ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization