BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3192658 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02591
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A MISSING END CAP STICKER, AND WAS RECEIVED WITH CRACKED WINDOW CORNERS. THE MOTOR PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRACK NEAR THE DISPLAY. IT WAS NOT KNOWN HOW THE CRACK OCCURRED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292620 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1