BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1830091 · Received September 7, 2010

    Report

    Report Number
    2032227-2010-82574
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 14, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER REPORTED A FROZEN DISPLAY. INITIAL TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS GIVEN INSTRUCTIONS FOR FURTHER TROUBLESHOOTING, AND WAS ADVISED TO CALL BACK IF THE ISSUE CONTINUED. FOLLOW UP CALLS WERE MADE TO THE CUSTOMER, BUT THERE WAS NO ANSWER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR