BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2133677 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01410
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    A NURSE CALLED FOR ASSISTANCE IN LOCATING THE BASAL RATES IN THE INSULIN PUMP PROGRAMMING. THE CALLER STATED THAT THE CUSTOMER HAD BEEN TREATING BY BOLUSING WITH THE INSULIN PUMP AND ALSO BY GIVING MANUAL INJECTIONS. THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS, AND WAS HOSPITALIZED SEVERAL TIMES. FOUND THAT THE CUSTOMER'S DOCTOR DID NOT KNOW THAT THE BASAL RATES WERE A CONSTANT BACKGROUND DELIVERY, AND HAD ORDERED THE CUSTOMER TO DELIVER BOLUSES AND MANUAL INJECTIONS. THE CUSTOMER WAS NOT PRESENT AT THE TIME OF THE CALL. TROUBLESHOOTING WAS NOT POSSIBLE. 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 Hospitalization