BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1811035 · Received August 10, 2010

    Report

    Report Number
    2032227-2010-82210
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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 WAS RECEIVED WITH A BLANK DISPLAY DUE TO A PROBLEM WITH THE INTERFACE BOARD. UNABLE TO VERIFY THE ALARMS DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AND THE DISPLAY WENT BLANK. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NOT RESOLVED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR