BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3052379 · Received April 11, 2013

    Report

    Report Number
    2032227-2013-01316
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE/FLUSH MOTOR SUPPORT DISK. THE INSULIN PUMP ALSO HAD A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN SQUIRTED OUT 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
    155590 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1