BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1915810 · Received November 30, 2010

    Report

    Report Number
    2032227-2010-83300
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 23, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 HAVING LOW BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED FOR LOW GLUCOSE LEVEL BELOW 50MG/DL. THE CUSTOMER DID HAVE SIGNS OF WEAKNESS AND SHAKING. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY, BASALS, TIME, AND DAILY TOTALS WERE CORRECT. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST SUCCESSFULLY. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization