BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1214022 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01846
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST DUE TO THE MOTOR ENCODER SIGNAL BEING OUT OF PHASE. HOWEVER, THE INSULIN PUMP PASSED THE BASIC OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY WHEN THE RESERVOIR WAS EMPTY. HOWEVER, THE INSULIN PUMP READ THAT THERE WERE STILL 80 UNITS REMAINING IN THE RESERVOIR. THE CUSTOMER WAS INSTRUCTED NO REWIND THE INSULIN PUMP AND PRIME THE INFUSION SET AGAIN. THE CUSTOMER STATED THAT THERE WERE ONLY 100 UNITS OF INSULIN REMAINING IN THE RESERVOIR, BUT THE INSULIN PUMP READ THAT THERE WERE 160 UNITS REMAINING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR