BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    MDR report key: 1031852 · Received April 16, 2008

    Report

    Report Number
    2032227-2008-00644
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON/KEYPAD RESPONSE DUE TO A FLATTENED ACT BUTTON/KEYPAD DOME.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE CALLED STATING THAT THE BUTTONS WERE NOT RESPONDING ON THE INSULIN PUMP. THE CUSTOMER PRESSED A BUTTON TO EXIT THE MANUAL PRIME SCREEN, BUT THE INSULIN PUMP DID NOT EXIT. THE INSULIN PUMP REMAINED IN THE MANUAL PRIME SCREEN AND THE CUSTOMER CONNECTED TO THE INFUSION SET. THE CUSTOMER RECEIVED A LARGE AMOUNT OF INSULIN AND HAD TO BE TREATED BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715RNAS PRDGM INS SK EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention