BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 4141768 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33538
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    May 28, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED 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.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE QUICKSET SERTER. CUSTOMER STATED THAT WHEN SHE INSERTS, THE STICKY PART GETS STUCK BETWEEN THE WHITE AND BLUE PART. CUSTOMER REMEMBERED THIS HAPPENING ON THE (B)(6) 2014 ORDER. CUSTOMER STATED THAT SHE WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 120 MG/DL, BUT NOTICED HER BLOOD GLUCOSE LEVEL WAS 420 MG/DL AFTER EXERCISING. CUSTOMER STATED THAT SHE ALSO HAD A BENT CANNULA SINCE THE QUICKSERTER DID NOT CORRECTLY INSERT HER INFUSION SET. CUSTOMER WAS ADVISED TO RETURN THE SERTER IF AVAILABLE. SERTER WILL NEED TO BE REPLACED. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621086 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR