BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3820281 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-84804
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 10, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED THE MOTOR TEST. THE DEVICE WAS RECEIVED WITH SCRATCHED SCREEN, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR NEAR THE TUBE WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299498 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-515WWS

    Patients

    Seq Age Sex Outcome Treatment
    1