BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-754LWWS PRDGM INS SK LN

    MDR report key: 1872056 · Received October 8, 2010

    Report

    Report Number
    2032227-2010-82866
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. UNABLE TO TROUBLESHOOT AS THE CALLER DID NOT HAVE THE INSULIN PUMP. UNABLE TO REACH THE CUSTOMER AT THE PHONE NUMBER PROVIDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-754LWWS PRDGM INS SK LN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization