BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-712LWWS PRDGM INS SK EN LN

    MDR report key: 1843629 · Received September 20, 2010

    Report

    Report Number
    2032227-2010-82681
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE INSULIN PUMP HAD A FROZEN SCREEN AND UNRESPONSIVE BUTTONS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. HOWEVER, THE ALARM COULD NOT BE CLEARED DUE TO THE UNRESPONSIVE BUTTONS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LWWS PRDGM INS SK EN LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1