BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2123162 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01435
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2011-81756.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SENSOR ERROR AFTER INITIALIZING. THE CUSTOMER THEN STATED THAT SHE WAS IN THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVELS, GASTROPARESIS AND HYPERTENSION. THE CUSTOMER ALSO STATED THAT SHE WORE THE SENSOR DURING AN MRI SCAN. TROUBLESHOOTING WAS PERFORMED, AND THE SENSOR WAS FUNCTIONING. 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 D131

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization