BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR BSA

    MDR report key: 3112532 · Received May 14, 2013

    Report

    Report Number
    2032227-2013-01954
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 SHE HAS HAD SEVERAL ISSUES WITH THE SENSOR INSERTION NEEDLES BEING DIFFICULT TO REMOVE. THE CUSTOMER STATED THAT ONE OF THEM ACTUALLY BROKE OFF UNDERNEATH HER SKIN AND SHE HAD TO REMOVE IT WITH TWEEZERS. THE CUSTOMER DID NOT SAVE THE SENSOR NEEDLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212349 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C L202

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR