BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2202409 · Received August 4, 2011

    Report

    Report Number
    2032227-2011-01957
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HALF OF THE SENSOR WAS MISSING WHEN SHE REMOVED IT FROM HER BODY. THE CUSTOMER WAS CONCERNED THAT THE OTHER HALF MAY HAVE STAYED UNDERNEATH HER SKIN. THE CUSTOMER WENT TO THE EMERGENCY ROOM TO HAVE AN X-RAY TAKEN. THE X-RAY WAS NEGATIVE. THE CUSTOMER WAS ADVISED TO RETURN THE SENSOR FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C D071

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization