BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3191796 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95091
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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. UNABLE TO CONFIRM THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 153MG/DL. THE CALLER STATED THAT THE INSULIN PUMP ALARMED, AND THEN IT GOES BLANK. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS SLIGHTLY INDENTED. ADVISED THE CALLER TO DISCONTINUE THE 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
    289717 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR