BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4173607 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38607
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED 1 OPENED/USED ENLITE-SENSOR AND PERFORMED VISUAL INSPECTION AND FAILED PER SPEC. FOUND CANNULA BENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER SENSORS WERE NOT CONNECTING. THE CUSTOMER ALSO REPORTED PAIN FROM HER SENSOR. CUSTOMER'S BLOOD GLUCOSE WAS 101 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653792 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C K203

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR