BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512RNAB PRDGM INS BL EN US RC

    MDR report key: 1843460 · Received September 20, 2010

    Report

    Report Number
    2032227-2010-82691
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 REPORTED THAT SHE WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS ABOVE 900 MG/DL ABOUT A MONTH AGO. THE CUSTOMER DECLINED TROUBLESHOOTING AND STATED THAT THE INSULIN PUMP IS WORKING FINE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512RNAB PRDGM INS BL EN US RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization