BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 3935847 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03859
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    CUSTOMER REPORTED THE SERTER IS BROKEN. CUSTOMER STATES THAT THE NEEDLE OF THE SENSOR ONLY GOES IN HALF WAY, MOVES, AND THEN BRAKES. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 200 MG/DL. CUSTOMER WAS ADVISED OF HOW TO PROPERLY USE THE SERTER, SO INFUSION SETS WON'T CONTINUE TO STAY STUCK IN THE SERTER. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413511 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR