BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    MDR report key: 1941867 · Received December 22, 2010

    Report

    Report Number
    2032227-2010-83523
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 415 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME, HIGH PRESSURE AND SELF TESTS. 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 54 YR Hospitalization