BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP MMT-642

    MDR report key: 2090920 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01119
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2011-01118.

    Description of Event or Problem · 1

    THE CUSTOMER WAS TREATED BY THE PARAMEDICS DUE TO HIGH BLOOD GLUCOSE LEVELS OF 405 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELT CLIP MMT-642 ACCESSORIES MDS MEDTRONIC MINIMED MMT-642

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention