BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2791845 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07435
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 7, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, BUT THE CUSTOMER WAS DISCONNECTED DURING PRIME. IT WAS STATED THAT THE PISTON CONTINUES MOVING FORWARD AFTER THE RESERVOIR MAKES CONTACT AND INSULIN SQUIRTS OUT. IT WAS MENTIONED THAT THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND THE BEEPS COULD NOT BE HEARD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG LZG MEDTRONIC MINIMED MMT-512LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1