BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR,MMT-7002C,10OK,GLUCOSE,BSA,17L

    MDR report key: 2151553 · Received June 28, 2011

    Report

    Report Number
    2032227-2011-01596
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE CUSTOMER CALLED FROM THE HOSPITAL TO REPORT TWO CALIBRATION ERRORS AND A CHANGE SENSOR ALARM. THE CUSTOMER WAS NOT HOSPITALIZED DUE TO DIABETES RELATED ISSUES, BUT WAS EXPERIENCING A BLOOD GLUCOSE READING OF 330 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS IN A HURRY, AND ONLY WANTED TO KNOW IF HE SHOULD CHANGE THE SENSOR. ADVISED HIM THAT HE WILL NEED TO CHANGE THE SENSOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR,MMT-7002C,10OK,GLUCOSE,BSA,17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization