BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR BSA

    MDR report key: 4233806 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48870
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT A SENSOR WAS INSERTED AND THE NEEDLE INSERTED FINE BUT IT WAS NOTICED THAT THE THERE WAS NO ACTUAL SENSOR BENEATH THE SKIN. THE SENSOR WAS PULLED OUT AND NO SENSOR WAS FOUND AT ALL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714725 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002E G104

    Patients

    Seq Age Sex Outcome Treatment
    1