BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR BSA

    MDR report key: 3122951 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-02027
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER STATED THAT THE SENSOR MAY HAVE BROKEN OFF INSIDE HER SKIN. THE CUSTOMER STATED THAT SHE BENT OVER, AND FELT PAIN BUT DIDN'T THINK MUCH OF IT. THE CUSTOMER LATER NOTICED THAT HER SITE WAS BRUISED. THE CUSTOMER DID NOT NOTICE ANY DAMAGE ON THE SENSOR, BUT DIDN'T REALLY INSPECT IT EITHER, AS SHE WAS IN A HURRY TO CHANGE IT. THE CUSTOMER HAS NOT HAD THE AREA LOOKED AT BY A PHYSICIAN, BUT SHE STATED THAT SHE WORKS IN A HOSPITAL AND CAN HAVE IT LOOKED AT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224111 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR