BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAL PRDGM INS CL EN US RC

    MDR report key: 1840913 · Received September 17, 2010

    Report

    Report Number
    2032227-2010-82663
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LGZ
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WIL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS WITH A READING OF 17 MG/DL. THE CUSTOMER WAS UNCONSCIOUS IN THE INTENSIVE CARE UNIT AT THE TIME OF THE CALL. IT WAS STATED THAT THE DOCTOR CHECKED THE PROGRAMMING, AND FOUND A BASAL RATE OF 35.0 PROGRAMMED FROM 9PM TO 12AM. THE DOCTOR WAS UNABLE TO CHANGE IT. THE TERRITORY MANAGER WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712RNAL PRDGM INS CL EN US RC INFUSION PUMP LGZ MEDTRONIC MINIMED MMT-712RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization