BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1850155 · Received September 22, 2010

    Report

    Report Number
    2032227-2010-82712
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 24, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY DUE TO A PROBLEM WITH THE MOTHER BOARD. NO BLANK DISPLAY WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS 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-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR