BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET® PARADIGM®

    MDR report key: 8806210 · Received July 19, 2019

    Report

    Report Number
    3003442380-2019-01632
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Product Code
    FPA
    UDI-DI
    05705244006775
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT NOTICED INSULIN COMING OUT OF THE TUBING UNKNOWN HOURS AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH SEVERAL NOT EXACTLY KNOWN SETS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599584 QUICK-SET® PARADIGM® QUICK-SET 110/9 PCC FPA 5179732 05705244006775

    Patients

    Seq Age Sex Outcome Treatment
    1