BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4233534 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48797
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 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

    RELIABILITY ANALYSIS INSPECTED 1 OPENED QUICK-SERTER FOR LOCKING AND PROPER OPERATION PER DES8570 AND D6024548-011 IFU, SECTION 1 TO 6 AND PERFORMED INSERTION TEST USING A NEW LAB QUICK-SET ONTO RUBBER SKIN. QUICK-SERTER FAILED PER INSPECTION FOUND THE QUICK-SERTER BARREL WALLS WITH EXCESSIVE GLUE FROM QUICK-SET TAPE.

    Description of Event or Problem · 1

    WHILE REPORTING AN ISSUE WITH THE FUNCTION OF THE QUICK SERTER, CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 461 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713274 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR