BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAS PRDGM INS SK EN US RC

    MDR report key: 1031859 · Received April 16, 2008

    Report

    Report Number
    2032227-2008-00650
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 599 MG/DL. THE NURSE WANTED TO HAVE THE INSULIN PUMP CHECKED TO MAKE SURE IT WAS FUNCTIONING. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME AND HIGH PRESSURE TESTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization