BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB-BASED DATA MANAGEMENT

    MDR report key: 2033981 · Received March 18, 2011

    Report

    Report Number
    2032227-2011-00705
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P989922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 FOR ASSISTANCE WITH THE CARELINK SOFTWARE. THE CUSTOMER THEN MENTIONED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DEHYDRATION. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 200 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS WERE BEING CONTROLLED TOO TIGHTLY, CAUSING STRESS TO HER BODY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEB-BASED DATA MANAGEMENT CGMS SOFTWARE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization