BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 3945574 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04694
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    K992300
    Product Problem
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    EVALUATED 1 OPENED QUICK SETER FOR LOCKING AND PROPER OPERATION PER SPECIFICATION. PERFORMED INSERTION TEST USING A NEW LAB QUICK-SET ONTO RUBBER SKIN. QUICK-SERTER PASSED PER SPECIFICATION. FOUND QUICK-SET LOCKED AND INSERTED IN PLACE PROPERLY. BOTH TRIGGER BUTTONS RELEASES PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY WERE HAVING TROUBLE WITH THE INFUSION SETS STICKING ONTO THE SERTER. THEY PUSHED A COUPLE OF TIME TO ENSURE THAT THE INFUSION SET IS SECURELY IN PLACE ON THE SERTER BUT ONCE THE RELEASE BUTTONS WERE PUSHED, THE TAPING ON THE INFUSION SET GOT STUCK ONTO THE SERTER. THE CUSTOMER'S BLOOD GLUCOSE WAS 396 MG/DL, WHICH WAS TREATED WITH INSULIN. THE CUSTOMER STATED THAT MAYBE THE BLOOD GLUCOSE WAS HIGH BECAUSE EARLIER IT WAS LOW AND SHE OVERATE. SHE DID NOT WANT TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED THAT A REPLACEMENT SERTER WILL BE SENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425048 PARADIGM QUICKSERTER CGM MDS MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR