BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4223559 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47445
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    July 7, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    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. QUICK-SERTER FAILED PER INSPECTION FOUND THE QUICK-SERTER BARREL WALLS WITH EXCESSIVE GLUE FROM QUICK-SET TAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER WAS HAVING PROBLEMS WITH ADHESIVE GETTING STUCK IN SERTER WHEN ATTEMPTING INSERTION. CUSTOMER MENTIONED BEING HOSPITALIZED IN (B)(6). CUSTOMER WAS HOSPITALIZED FROM (B)(6), 2014 DUE TO HIGH BLOOD GLUCOSE OF OVER 500 MG/DL. CUSTOMER WAS WEARING INSULIN PUMP AT TIME OF HOSPITALIZATION. CUSTOMER STATES DOCTOR BELIEVED INSULIN PUMP WAS THE CAUSE OF HIGH BLOOD GLUCOSE. CUSTOMER WAS ADVISED ON PROPER USE OF SERTER AND ADVISED THAT SERTER WILL BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706568 PARADIGM QUICKSERTER CGM MDS MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization