BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1812967 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-82482
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE. HOWEVER, THE DEVICE PASSED THE PRIME, BASIC OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING A NO DELIVERY ALARM DURING A MANUAL PRIME. TROUBLESHOOTING WAS DECLINED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR