BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3900928 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-86303
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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 AN ERROR DURING THE PRIME TEST AND ALSO ALARMED MOTOR ERROR DURING REWIND AS A RESULT OF A LOOSE/PROTRUDED DRIVE SUPPORT DISK. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE UNIT WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND SCRATCHED SCREEN.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376964 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-515WWL

    Patients

    Seq Age Sex Outcome Treatment
    1