BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4191268 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41546
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INFUSION SETS WERE STUCK INSIDE THE SERTER. THE CUSTOMER'S BLOOD GLUCOSE WAS 450 MG/DL. SHE HAD TREATED HER HIGH BLOOD GLUCOSE WITH A MANUAL INJECTION. THE CUSTOMER REPORTED THAT THE INFUSION SET TAPE WAS STICKING TO THE SIDE OF THE SERTER. IT WAS FOUND THE ISSUE WAS NOT RESOLVED BY REVIEWING PROPER USE OF THE SERTER. THE CUSTOMER'S SERTER WILL BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669477 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR