BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1781279 · Received July 29, 2010

    Report

    Report Number
    3004209178-2010-82243
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS, MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A BLANK DISPLAY AS A RESULT OF CORROSION AT THE LIQUID CRYSTAL DISPLAY BOARD. ALSO, THE DEVICE HAD A LOOSE DISPLAY WINDOW. FURTHER TESTING WAS NOT PERFORMED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE REMOVED THE INFUSION SET, RAN A BOLUS AND THEN REATTACHED, BUT THE DEVICE HAD THE SAME ALARM. THE MOTHER STATED THAT THE DISPLAY OVERLAY WAS LIFTED. 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 17 YR