BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAB PRDGM INS BL EN US LN

    MDR report key: 1190055 · Received October 6, 2008

    Report

    Report Number
    2032227-2008-01735
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE 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

    CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 528MG/DL AT TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED AND THE BASAL RATES AND SETTINGS IN THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization