BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1811036 · Received August 10, 2010

    Report

    Report Number
    2032227-2010-82213
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC AND MOTOR ASSEMBLY. UNABLE TO CONFIRM THE BUTTON/KEYPAD ANOMALY OR ALARMS DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNRESPONSIVE BUTTONS, ALARMS AND A BLANK DISPLAY. THE CUSTOMER STATED THAT SHE WENT INTO THE POOL WITH THE INSULIN PUMP ON. 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-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR