BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2123359 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81727
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    March 23, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND A MOTOR ERROR ALARM OCCURRED DURING REWIND DUE TO AN OUT-OF-PHASE MOTOR ENCODER SIGNAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING THREE MOTOR ERROR ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1