BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC: QUICK-SET PARADIGM

    MDR report key: 6409710 · Received March 13, 2017

    Report

    Report Number
    MW5068472
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    November 19, 2016
    Report Date
    March 3, 2017
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED SUPPLY KIT; QUICK-SET PARADIGM WITH REF # MMT-397; LOT # 5139921; EXPIRY: 03-2019, FROM MEDTRONIC MEDICAL IN SEALED CONDITION VIA U. S. MAIL PARCEL. PT REMOVED QUICK-SET FROM PACKAGE AND NOTED "RED SUBSTANCE" IN TUBING CONNECTOR. THINKING RED SUBSTANCE PLASTIC PART OF TUBING PROCEEDED CONNECTING INSULIN RESERVOIR CARTRIDGE; PRIMING AND INSERTING CANNULA COMPLETING REPLACEMENT PROCESS. DURING PT CLEAN UP FOLLOWING REPLACEMENT PROCESS, PT NOTED "RED STAIN" ON TOWEL USED WHEN CHANGING QUICK-SET INFUSION SET. PT IMMEDIATELY DISCONNECTED REPLACEMENT QUICK-SET AND NOTED RED SUBSTANCE IN TUBING CONNECTOR SMEARED AND NOT PLASTIC. PT REPORTED TO ORLANDO VA MEDICAL CENTER'S ENDOCRINOLOGY SERVICE AND KEPT "SUSPECT" KIT TILL RETURNED OVAMC (B)(6) 2017. REPORTING THIS DATE AS THE "SUSPECT" MEDICAL DEVICE WAS DELIVERED FACILITY RECALL COORDINATOR AND REPORTING FDA THIS DATE. THIS ELECTRONIC REPORT WILL BE COMPLEMENTED WITH HARD COPY TO FDA WITH COLOR PHOTOS "SUSPECT" MEDICAL DEVICE. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182448 MEDTRONIC: QUICK-SET PARADIGM QUICK-SET PARADIGM FPA MEDTRONIC MINIMED 9MM X 60CM MMT-397 5139921

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR