BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4082434 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-20095
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ONE OPENED QUICK-SERTER WAS INSPECTED FOR LOCKING AND PROPER OPERATION. AN INSERTION TEST WAS PERFORMED USING A NEW LAB QUICK-SET ONTO RUBBER SKIN. THE QUICK-SERTER FAILED PER INSPECTION AND THE BARREL WALLS WERE FOUND WITH EXCESSIVE GLUE FROM THE QUICK-SET TAPE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SERTER WAS NOT FUNCTIONING PROPERLY AND WAS NO LONGER SPRINGY DURING INSERTION. CUSTOMER STATED THAT THE NEEDLE WAS NOT EJECTING FULLY AND THE ADHESIVE KEPT GETTING STUCK INSIDE THE SERTER. BLOOD GLUCOSE LEVEL WAS 47 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562811 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR