BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP,INSULIN,511 NA CLEAR

    MDR report key: 1230491 · Received February 2, 2008

    Report

    Report Number
    2032227-2007-00179
    Event Type
    Injury
    Date Received
    February 2, 2008
    Date of Event
    January 8, 2007
    Report Date
    January 24, 2007
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED BEING TREATED BY THE EMERGENCY MEDICAL TEAM FOR LOW BLOOD GLUCOSE. CUSTOMER ALSO MENTIONED HE EXPERIENCED AN INSULIN REACTION AN HOUR AFTER LAST BOLUS. DURING TROUBLESHOOTING IT WAS FOUND OUT THAT CUSTOMER BOLUSED TWICE WITHIN 60 MINUTES. THE INSULIN PUMP APPEARED TO BE FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,INSULIN,511 NA CLEAR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention