BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511NAB PRDGM EA INS BL EN

    MDR report key: 1062711 · Received June 16, 2008

    Report

    Report Number
    2032227-2008-00995
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INSULIN PUMP HAD A CRACK ON THE RESERVOIR COMPARTMENT. IT WAS ALSO STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT THE CRACK WAS AFFECTING THE DELIVERY OF INSULIN FROM THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN AS THE INSULIN PUMP NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511NAB PRDGM EA INS BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization