BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2161773 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01666
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    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 OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING INSULIN ABSORPTION ISSUES AND HIGH BLOOD GLUCOSE LEVELS. THE CALLER STATED THAT THE CUSTOMER'S HEALTHCARE PROFESSIONAL ADVISED HIM TO GO TO THE EMERGENCY ROOM DUE TO HIS ELEVATED BLOOD GLUCOSE LEVELS. THE CALLER STATED THAT THE CUSTOMER ROTATES HIS INSERTION SITES REGULARLY, BUT SHE WAS UNSURE IF HE HAD SCAR TISSUE. ADVISED HER TO HAVE HIM CHECKED FOR SCAR TISSUE, AND TO CALL BACK FOR TROUBLESHOOTING WHEN 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 39 YR Hospitalization