BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 3954128 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04679
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. SEE MEDWATCH REPORT # 2032227-2014-04680.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS HAVING ISSUES WITH THE SERTER. THE SENSOR NEEDLE HUB DIDN'T RELEASE FROM THE SERTER WHEN THE BUTTON WAS PRESSED. NO BLOOD GLUCOSE LEVEL WAS NOTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430579 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR