BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUM

    MDR report key: 3133948 · Received May 29, 2013

    Report

    Report Number
    2032227-2013-02186
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    September 26, 2012
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARM DURING THE PRIME TEST DUE TO PROTRUDED/LOOSE MOTOR DRIVE SUPPORT DISK. UNIT HAD MISSING END CAP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP INSULIN IS SQUIRTING THE INSULIN OUT, ALARMING DURING MANUAL PRIME AND UNABLE TO EXIT FROM PREPARING TO PRIME LOOP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235296 PARADIGM INSULIN INFUSION PUM INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR