BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1812323 · Received August 20, 2010

    Report

    Report Number
    2032227-2010-82393
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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 REPORTED, VIA EMAIL, THAT WHEN REMOVING THE SENSOR FROM THE INSERTION SITE, THE ACTUAL CATHETER STAYED INSIDE THE SKIN. THE CUSTOMER WENT TO THE EMERGENCY ROOM, BUT THEY WERE UNABLE TO DETECT IT WITH AN XRAY. THE CUSTOMER WILL BE SCHEDULED FOR AN MRI OR CT SCAN. 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 MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization