BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4150371 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35084
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 500 MG/DL. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATES THAT THE QUICK SERTER IS CAUSING BENT CANNULAS AND THAT THE SERTER DID NOT RELEASE THE INFUSION SET PROPERLY. THE OUTCOME OF THE ISSUE WAS THAT THE CUSTOMER REPLACED THE QUICK SERTER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628757 PARADIGM QUICKSERTER INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR