BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1812004 · Received August 17, 2010

    Report

    Report Number
    2032227-2010-82371
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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 STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS OF 465 MG/DL AND KETONES. THE CUSTOMER ALSO REPORTED NO DELIVERY ALARMS PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER WAS UNABLE TO VERIFY IF THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT SHE WAS GUESSING WHEN SHE PROGRAMMED HER BASAL RATES INTO THE INSULIN PUMP. THE INSULIN PUMP PASSED THE PRIME TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization