BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4233656 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48921
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 WAS REPORTED THAT THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. THE CUSTOMER ALSO REPORTED HER SERTER'S SPRING WAS BROKEN. SHE TREATED HER HIGH BLOOD GLUCOSE LEVEL WITH A MANUAL INJECTION. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715461 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other