BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAB PRDGM INS BL EN US LN

    MDR report key: 1081815 · Received July 23, 2008

    Report

    Report Number
    2032227-2008-01272
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER'S MOTHER STATED THE CUSTOMER WAS VERY ILL AND WHEN HE CHECKED HIS BLOOD GLUCOSE THE READING WAS 400 MG/DL. TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT THE CUSTOMER HAD LAST CHANGED HIS INFUSION SET TWO DAYS PRIOR TO THE EVENT. THE CUSTOMER'S DOCTOR ADVISED THAT THE INFUSION SITE BE CHANGED TO RULE OUT A POSSIBLE SITE PROBLEM. THE CUSTOMER'S DOCTOR WILL ALSO BE SWITCHING THE BRAND OF INSULIN THE CUSTOMER IS USING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAB PRDGM INS BL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization