BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1812298 · Received August 20, 2010

    Report

    Report Number
    2032227-2010-82386
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE CUSTOMER REPORTED A BUTTON ERROR ALARM, AS WELL AS BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER WAS DEHYDRATED AND HAD BLOOD GLUCOSE LEVELS ABOVE 600 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization