BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-508LUC EA INSULIN CH EN US LN

    MDR report key: 1811062 · Received August 10, 2010

    Report

    Report Number
    2032227-2010-82228
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPLAY WAS BLANK DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY ON THE INSULIN PUMP WAS BLANK. TROUBLESHOOTING WAS PERFORMED, BUT THE DISPLAY COULD NOT BE RESTORED. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HIS DIABETES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508LUC EA INSULIN CH EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LUC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR