BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1853282 · Received September 29, 2010

    Report

    Report Number
    2032227-2010-82784
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 521 MG/DL. THE DOCTOR FELT THAT THE CUSTOMER WAS NOT INSERTING THE INFUSION SET CORRECTLY AND NOT GETTING ENOUGH DEPTH. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization