BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4133311 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-10554
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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

    IT IS REPORTED THAT A CUSTOMER HAD A PROBLEM WITH A LEAK IN HIS INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT RECORDED. THE CUSTOMER STATED THAT THE LEAK IS COMING FROM THE INFUSION SET. THE OTHER PROBLEM THE CUSTOMER IS HAVING IS WITH THE ADHESIVE NOT STICKING TO THE INSIDE OF THE QUICKSERTER. THE CUSTOMER DID NOT WANT TO SPEAK TO THE HELPLINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610834 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR