BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1781333 · Received July 29, 2010

    Report

    Report Number
    3004209178-2010-82223
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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 A BROKEN SOLDER JOINT ON THE INTERFACE BOARD. FURTHER TESTING WAS NOT PERFORMED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD FAILED MULTIPLE TIMES THE BATTERY TEST AND THE DEVICE HAD A BLANK DISPLAY. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 390MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE DEVICE WAS UNRESPONSIVE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR