BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2081256 · Received April 26, 2011

    Report

    Report Number
    2032227-2011-01047
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THAT SHE WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS OVER 700 MG/DL. THE CUSTOMER WAS IN DIABETIC KETOACIDOSIS, AND HAD A HEART ATTACK. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER WAS UNABLE TO CONDUCT FURTHER TROUBLESHOOTING AT THE TIME OF THE CALL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization