BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    MDR report key: 1872036 · Received October 8, 2010

    Report

    Report Number
    2032227-2010-82883
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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 WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS ABOVE 1000 MG/DL. THE CUSTOMER DIDN'T WANT TO TROUBLESHOOT, AND WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715RNAS PRDGM INS SK EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization