BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1691814 · Received May 13, 2010

    Report

    Report Number
    2032227-2010-81196
    Event Type
    Death
    Date Received
    May 13, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 TERRITORY MANAGER CALLED TO REPORT THAT THE CUSTOMER PASSED AWAY, DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S SISTER WAS CONTACTED FOR FURTHER INFO, BUT SHE REFUSED TO SPEAK ABOUT THE DEATH OR ANSWER ANY QUESTIONS, UNLESS THEY WERE EMAILED TO HER. THE SISTER ALSO STATED THAT SHE WOULD LIKE TO SPEAK TO AN ATTORNEY BEFORE ANSWERING ANY QUESTIONS. IN ADDITION, THE CUSTOMER DIDN'T' WANT TO RETURN THE INSULIN PUMP FOR TESTING. SHE WANTED TO HAVE SOMEONE ELSE LOOK AT IT AND POSSIBLY TEST IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAB PRDGM INS BL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death