BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 3945572 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04542
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 ISSUES WITH THE SERTER. CUSTOMER STATED THE INFUSION SET DOES NOT FIT PROPERLY IN THE SERTER OR ADHESIVE IS STICKING TO THE SERTER. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424701 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR