BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 4233659 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48924
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 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
    TX
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH HIS SERTER. THE CATCH ARM WAS BENT MAKING IT DIFFICULT TO REMOVE THE SENSOR FROM THE SERTER DEVICE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. HE ALSO REPORTED THAT ALMOST ALL OF HIS SENSORS WERE BENT UPON REMOVAL AND NEVER HAD A SUCCESSFUL INSERTION. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715473 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR