BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR,MMT-7002D,4PK,GLUCOSE,BSA,17L

    MDR report key: 1911890 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83289
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT TWO SENSORS SEEMED TO HAVE A BENT NEEDLE PREVENTING THE COMPLETE REMOVAL OF THE INSERTION NEEDLE FROM THE SENSOR CATHETER. THE CUSTOMER STATED THAT IN ONE CASE WHEN THE SENSOR WAS ATTEMPTED TO REMOVE, IT ACCIDENTALLY CAUSED THE NEEDLE TO SNAP. THE INTER-PART, THE CATHETER, AND THE NEEDLE POINT FROM THE CUSTOMER WERE REMOVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR,MMT-7002D,4PK,GLUCOSE,BSA,17L GLUCOSE SENSOR MDS MEDTRONIC MINIMED MMT-7002D G200

    Patients

    Seq Age Sex Outcome Treatment
    1