BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT SET INFUSION SET

    MDR report key: 5484470 · Received March 7, 2016

    Report

    Report Number
    2032227-2016-04024
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    September 1, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY THE DAY OF THE CALL. THE CUSTOMER STATED THAT THE ALARM WAS DUE TO THE INFUSION SET CANNULA BEING BENT. THE CUSTOMER ALSO REPORTED HAVING 6 INFUSION SET CANNULAS BEND SINCE (B)(6) 2015. THE CUSTOMER STATED HER ENDOCRINOLOGIST SUGGESTED TRYING DIFFERENT INFUSION SET TYPES. THE CUSTOMER WOULD CALL BACK WITH THE PRODUCT INFORMATION AND ORDER NEW INFUSION SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140299 SOFT SET INFUSION SET FPA FPA MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR