BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 3801080 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02119
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2014-84057.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 700 MG/DL. THE PATIENT ALSO STATED THAT SHE WAS HAVING PROBLEMS WITH THE INSERTION DEVICE NOT INSERTING PROPERLY. THE PATIENT FELT THAT IT WAS WEAK, AND NOT INSERTING WITH AS MUCH FORCE AS IT USED TO. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277949 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization