BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3092915 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01611
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AND SQUIRTED OUT INSULIN DURING THE MANUAL PRIME. THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND NO BEEPS WERE HEARD. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195158 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1