BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4090341 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-19181
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    March 4, 2013
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS AS A RESULT OF CORRODED KEYPAD TRACES. UNABLE TO CONFIRM THE ALARM. THE DEVICE WAS RECEIVED WITH SCRATCHED SCREEN, CRACKED RESERVOIR TUBE LIP AND TUBE THREADS AS WELL WITH MISSING END CAP STICKER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD A BUTTON ERROR ALARM AND THE ESCAPE AND ACTIVATE BUTTONS WERE NOT RESPONDING. ADVISED THE CALLER TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568960 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1