BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-712WWS

    MDR report key: 2003846 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80334
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY DURING SELF TEST. PROBLEM ISOLATED TO THE MOTHERBOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP STOPPED DURING SELF TEST, AND THE CASE WAS CRACKED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP MMT-712WWS INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWS

    Patients

    Seq Age Sex Outcome Treatment
    1